Showing posts with label FDA. Show all posts

Friday, June 19, 2015

11 CHARGED IN CONSPIRACY TO MANUFACTURE, DISTRIBUTE COUNTERFEIT 5-HOUR ENERGY DRINK

FROM: U.S. JUSTICE DEPARTMENT
Friday, June 19, 2015
Eleven Defendants Charged in Nationwide Conspiracy to Manufacture and Distribute Counterfeit 5-Hour ENERGY Drink
Defendants Sold Millions of Bottles of Counterfeit 5-Hour ENERGY Drink

U.S. Attorney Melinda Haag of the Northern District of California, Special Agent in Charge David J. Johnson of the FBI’s San Francisco Field Office and Special Agent in Charge Lisa L. Malinowsk of the U.S. Food and Drug Administration’s (FDA) Los Angeles Field Office of Criminal Investigations announced today that 10 people were arrested after being charged with conspiracy to traffic in counterfeit goods, conspiracy to commit criminal copyright infringement and conspiracy to introduce misbranded food into interstate commerce. The defendants were arrested on charges stemming from the illegal distribution and counterfeit of the liquid dietary supplement 5-Hour ENERGY. One further defendant was not arrested but remains subject to an arrest warrant.

According to the indictment that was unsealed yesterday, all 11 defendants were involved in the illegal repackaging and eventual counterfeiting of 5-Hour ENERGY. The supplement is owned by a group of entities referred to in the indictment as Living Essentials, which manufactured all 5-Hour ENERGY at factories in Wabash, Indiana. Living Essentials has registered and owns all 5-Hour ENERGY trademarks and a copyright, including the “5-Hour ENERGY” name and various graphical elements of the product’s labeling and packaging. The 5-Hour ENERGY trademarks and copyrighted material are displayed on every bottle of 5-Hour ENERGY and display boxes. Living Essentials does not provide licenses to any individual or entity to manufacture 5-Hour ENERGY.

According to the indictment, defendants Joseph Shayota and Adriana Shayota, his wife, through their company Baja Exporting LLC, agreed with Living Essentials to distribute 5-Hour ENERGY in Mexico. Living Essentials manufactured the liquid 5-Hour ENERGY product and provided Spanish-language labeling and display boxes to Baja Exporting. Living Essentials additionally provided Baja a complete product package under the agreement that the 5-Hour ENERGY with Spanish-language labeling was only to be distributed by Baja in Mexico. Nevertheless, according to the indictment, rather than distributing authentic 5-Hour ENERGY with Spanish-language labeling in Mexico, the defendants attempted instead to divert the product and to sell it in the United States at a higher price. After initial efforts to sell the product failed because of the Spanish-language labeling and display boxes, the defendants replaced the labeling and display boxes with counterfeit labels and boxes designed to imitate Living Essentials’ packaging in the United States. The defendants repackaged over 350,000 bottles of 5-Hour ENERGY and sold them in the United States at a price that was 15 percent lower than what Living Essentials charged for authentic United States 5-Hour ENERGY. By December 2011, Joseph and Adriana Shayota had sold off Baja’s remaining stock of the repackaged/relabeled 5-Hour ENERGY.

Also according to the indictment, by early 2012, the defendants had moved into counterfeiting the entire 5-Hour ENERGY product. The defendants manufactured the counterfeit 5-Hour ENERGY liquid at an unsanitary facility using untrained day workers. The defendants mixed unregulated ingredients in plastic vats while attempting to mimic the real 5-Hour ENERGY products.

From December 2011 through October 2012, the defendants allegedly ordered more than seven million counterfeit label sleeves and hundreds of thousands of counterfeit display boxes and placed false lot and expiration codes on the bottles and boxes. The defendants often changed the lot and expiration codes on the counterfeit bottles and boxes to parallel the valid codes being used on the authentic product.

The indictment further alleges that the defendants travelled to Guadalajara, Mexico, and hired manufacturers for the blank plastic bottles and plastic bottle caps imprinted with the Living Essentials-trademarked “Running Man” logo. They also purchased equipment, including a steam tunnel machine, to shrink-wrap the counterfeit 5-Hour ENERGY labels on the counterfeit bottles and an inkjet printer to place false lot numbers and expiration dates on the bottoms of the counterfeit bottles.

The defendants also allegedly used code words in purchase orders and invoices for counterfeit 5-Hour ENERGY. For example, defendants Walid Jamil, Juan Romero and Leslie Roman referred to the counterfeit 5-Hour ENERGY liquid contents as “michelada,” “juice blend” and “spices.”

In addition, the indictment alleges that from May 2012 to October 2012, Midwest Wholesale Distributors, a company owned by Jamil, distributed more than four million bottles of counterfeit 5-Hour ENERGY into commercial channels throughout the United States. Midwest sold approximately 508,032 counterfeit 5-Hour ENERGY bottles to Baja Exporting and 3,521,232 counterfeit 5-Hour ENERGY bottles to the Dan-Dee Company, which was owned by defendants Kevin Attiq and Raid Attiq. A partial list of retail vendors and wholesale distributors to whom the alleged counterfeit product was sold is attached.

“The defendants’ alleged conduct demonstrates a complete disregard of the health and safety of consumers,” said U.S. Attorney Haag. “My office will continue to vigorously prosecute those individuals who place greed over the well-being of the community by distributing counterfeit dietary products.”

“The business of trafficking in counterfeit merchandise harms victims in many ways," said Special Agent in Charge Johnson. “Intellectual property crimes are anything but victimless. Intellectual property crimes can destroy jobs, suppress innovation and jeopardize the public health and safety. In this complex case, the suspects allegedly produced a product to counterfeit a popular dietary supplement that was ultimately consumed by the public. The FBI and its partners will continue to bring these types of criminals to justice.”

“U.S. consumers rely on FDA oversight of foods to ensure that they are safe and wholesome,” said Special Agent in Charge Malinowski. “Criminals who produce and sell counterfeit and misbranded dietary supplements put the public health at risk by utilizing unknown and unregulated ingredients that could put the consumer in danger of serious illness or death. This alleged counterfeit operation was especially egregious as the investigation revealed this product was sold, distributed and placed on the shelves of numerous retailers throughout the United States. We will continue to investigate violators of our laws and work to bring them to justice.”

The 11 indicted defendants, all of whom are charged with conspiracy to traffic in counterfeit goods, conspiracy to commit criminal copyright infringement and conspiracy to introduce misbranded food into interstate commerce, include:

Joseph Shayota, 63, of El Cajon, California. Shayota was arrested yesterday at his residence. He made an initial appearance before the Honorable U.S. Magistrate Judge Nita L. Stormes in the Southern District of California, who ordered him released on $250,000 bond and to surrender his passport. Shayota’s next scheduled court appearance will be on July 9, 2015, at 1:30 p.m., before the Honorable U.S. Magistrate Judge Howard R. Lloyd to schedule further proceedings in U.S. District Court in San Jose, California.

Adriana Shayota, 44, also of El Cajon. Shayota was arrested yesterday at her residence. She made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who ordered her released on $100,000 bond and to surrender her passport. Shayota’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Justin Shayota, 32, of Troy, Michigan. Shayota was arrested yesterday at his residence. He made an initial appearance before the Honorable U.S. Magistrate Judge David T. Grand in the Eastern District of Michigan, who ordered him released on a $10,000 unsecured bond and to surrender his passport by noon tomorrow. Shayota’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Walid Jamil, aka Wally Jamil, 65, also of Troy. Jamil self-surrendered to the FBI yesterday. He made an initial appearance before U.S. Magistrate Judge Grand in the Eastern District of Michigan, who ordered him released on a $10,000 unsecured bond and to surrender his passport by noon tomorrow. Jamil’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before the U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Raid Jamil, aka Brian Jamil, 46, of West Bloomfield, Michigan. Jamil surrendered to the FBI yesterday. He made an initial appearance before U.S. Magistrate Judge Grand in the Eastern District of Michigan, who ordered him released on a $10,000 unsecured bond and to surrender his passport by noon tomorrow. Jamil’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Kevin Attiq, 51, of El Cajon. Attiq was arrested yesterday at his residence. He made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who released him on $100,000 bond and to surrender his passport. Attiq’s next scheduled court appearance is on July 9, 2015, before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Fadi Attiq, 57, of El Cajon. Attiq was arrested yesterday at his residence. He made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who released him on $100,000 bond and to surrender his passport. Attiq’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Leslie Roman, 61, of Rancho Cucamonga, California. Roman was arrested yesterday at his residence. He made an initial appearance before the Honorable U.S. Magistrate Judge David T. Bristow in the Central District of California, who released him on $50,000 bond after he surrendered his passport. Roman’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Mario Ramirez, 55, of San Diego.Ramirez was arrested yesterday at his residence. He made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who released him on $100,000 cash via cashier’s check and ordered him to surrender his passport. Ramirez’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Camilo Ramirez, 30, of San Diego. Ramirez was arrested yesterday at his residence. He made an initial appearance before U.S. Magistrate Judge Stormes in the Southern District of California, who released him on $100,000 cash via cashier’s check and ordered him to surrender his passport. Ramirez’s next scheduled court appearance is on July 9, 2015, at 1:30 p.m., before U.S. Magistrate Judge Lloyd to schedule further proceedings in U.S. District Court in San Jose.

Juan Romero, 68, of Upland, California. An arrest warrant remains outstanding for Romero.

An indictment merely alleges that crimes have been committed, and all defendants are presumed innocent until proven guilty beyond a reasonable doubt. If convicted, the defendants face the following maximum statutory penalties:

For each count of conspiracy to traffic in counterfeit goods: 10 years imprisonment, a $2 million fine, three years of supervised release and a $100 special assessment.

For each count of conspiracy to commit criminal copyright infringement: five years imprisonment, a $250,000 fine, three years of supervised release and a $100 special assessment.

For each count of conspiracy to introduce misbranded food into interstate commerce: five years imprisonment, a $250,000 fine, three years of supervised release and a $100 special assessment.

However, any sentence following conviction would be imposed by the court after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence.

Assistant U.S. Attorneys Matt Parrella and Susan Knight of the Northern District of California are prosecuting the case with the assistance of Elise Etter. The prosecution is the result of an investigation by the FBI and the FDA’s Office of Criminal Investigations.

Sunday, June 7, 2015

U.S. FDA PROGRAM TO EXPEDITE REVIEW FOR CERTAIN FOOD IMPORTERS

FROM: U.S. FOOD AND DRUG ADMINISTRATION
New FDA Program Will Benefit Both Importers and Consumers
June 4, 2015

The U.S. Food and Drug Administration is establishing a voluntary, fee-based program for the expedited review and importation of foods into the United States from importers with a proven food safety track record. The FDA is publishing a draft guidance for industry to explain how this new program will work.

The Voluntary Qualified Importer Program (VQIP) will benefit both industry and consumers.

Importers with a robust system of supply-chain management will receive expedited entry for imported foods that are in the program.
Consumer protections are strengthened by enabling the FDA to focus its resources on food imports that are more likely to present a potential risk to public health.

The FDA Food Safety Modernization Act, signed into law in January 2011, provides the FDA with new authorities to ensure that foods imported into the United States meet the same safety standards as those set for domestically produced foods.

In addition to establishing mandatory standards for importers of food under the Foreign Supplier Verification Program (FSVP), FSMA also requires the FDA to establish VQIP for importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes importation of food from facilities that have been certified as following appropriate food safety practices under FDA’s Accredited Third-Party Certification regulations, also required by FSMA.

FDA is issuing a notice in the Federal Register announcing the availability of a draft guidance entitled “Draft Guidance for Industry on the Voluntary Qualified Importer Program for Food Importers and Guidelines in Consideration of the Burden of the VQIP Fee Amounts on Small Business.”

The draft guidance document outlines VQIP provisions and provides information on:

the benefits VQIP importers can expect to receive;
eligibility criteria;
instructions for completing a VQIP application;
conditions that could result in revocation of VQIP participation; and
criteria for VQIP reinstatement following revocation.
In addition, the Notice of Availability provides a preliminary estimate of the fee for the program and requests comment on whether and how this amount would be a burden for small businesses.

There will be a public comment period of 75 days on the draft guidance and the guidelines related to the burden of fees on small businesses. After comments are considered and the guidance finalized, the program is expected to be open for applications in January 2018 to allow enough time for a facility to be certified under FDA’s Accredited Third Party Certification program.

Wednesday, April 29, 2015

FDA APPROVES FIRST GENERIC VERSIONS OF DRUG APPROVED TO TREAT SCHIZOPHRENIA, BIPOLAR DISORDER

FROM: U.S. FOOD AND DRUG ADMINISTRATION

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.

Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

Schizophrenia is a chronic, severe and disabling brain disorder. About one percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of schizophrenia include hearing voices, believing other people are reading their minds or controlling thoughts and being suspicious or withdrawn.

Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

All atypical antipsychotics contain a Boxed Warning alerting health care professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.

Wednesday, March 25, 2015

FDA ASKS "ARE SOME COSMETICS PROMISING TOO MUCH?"

FROM: FOOD AND DRUG ADMINISTRATION

Americans spend a lot of money on creams, lotions and other cosmetics that promise to improve their skin, hair, and even eyelashes.
But sometimes those promises go too far.

The Food and Drug Administration (FDA) warns cosmetics companies when they make claims about their products that classify them as drugs, not cosmetics. FDA has issued warning letters citing drug claims associated with topical skin care, hair care, and eyelash/eyebrow preparations, noted on both product labeling and Web sites. Some examples of the drug claims cited are acne treatment, dandruff treatment and hair restoration.

These letters state that the products are being marketed with drug claims—indicating that they are intended to treat or prevent disease, or change the body’s structure or functions. The agency tells companies that they need to remove any drug claims from their products’ labeling or seek FDA approval to market these products as drugs.

“Consumers need to know that these drug claims have not been proven to FDA when they are making a decision to purchase one of these products,” says Linda M. Katz, M.D., MPH, director of FDA’s Office of Cosmetics and Colors. “These products must be evaluated by FDA as drugs before the companies can make claims about changing the skin or treating disease.”

Some of the drug claims have included promises to increase production of collagen and elastin, resulting in skin that is more elastic and firmer, with fewer wrinkles.

Some get even more specific, such as claims that products reduce inflammation, regenerate cells, prevent facial muscle contractions, boost activity of genes, or give you the same results as injections or surgery. Others promise to treat medical conditions, such as acne, rosacea, eczema, and psoriasis.

Wednesday, March 4, 2015

SEAFOOD COMPANY OWNER SENT TO PRISON FOR DEALING IN ILLEGAL OYSTERS

FROM: U.S. JUSTICE DEPARTMENT I
Monday, March 2, 2015
Delaware Seafood Wholesaler and Company Fined and Owner Sentenced to 26 Months in Prison for Illegally Trafficking in Oysters

Mark Bryan, 59, of New Market, Maryland, and his Delaware-based seafood wholesale business, Harbor House Seafood, were sentenced on Friday in federal court in Camden, New Jersey, for trafficking in illegally possessed oysters, creating false health and safety records, and conspiracy charges.

Bryan was sentenced to serve 26 months in prison followed by three years of supervised release. Bryan was also ordered to pay a $62,500 fine and to pay New Jersey $140,000 for the restoration of oyster beds in Delaware Bay. Harbor House was ordered to pay a $250,000 fine and was sentenced to five years of probation. Friday’s sentences, in addition to the previous sentencing of Bryan’s co-conspirators and suppliers, brings the total fines and forfeitures in this matter to over $625,000, along with $194,000 of restoration costs..

Bryan and Harbor House were convicted in 2012 of multiple felony crimes related to dealings in illegal oysters from 2004 to 2007. The evidence showed that for more than four years, Bryan conspired with New Jersey oystermen Thomas Reeves and Todd Reeves to cover up the Reeves’ overharvest of oysters from the Delaware Bay. Bryan, through his company, Harbor House Seafood, purchased the illegal oysters from the Reeves, then assisted in covering up the Reeves’ overharvest by maintaining double-books, providing federal agents with false records, and by falsifying his FDA-mandated health and safety logs. The jury saw numerous instances of late-night faxes between Bryan and the Reeves which were used to coordinate their conspiracy and hide their wrong-doing from investigators. Bryan was also shown to have purchased illegal oysters from oyster harvester Kenneth Bailey of New Jersey. During the course of his crimes, Bryan moved, purchased and sold over $1.2 million worth of illegal oysters.

The Reeves and Bailey were previously sentenced on Feb. 11, 2015, to 26 months, 16 months, and 12 months in prison, respectively, for their roles.

“The defendants’ actions provided a market for dishonest oystermen who were willing to place natural resources at risk in the name of profit,” said Assistant Attorney General John C. Cruden of the Department of Justice’s Environment and Natural Resources Division. “Today’s sentences send the message that those who knowingly deal in illegal natural resources will be held accountable.”

“Today's sentence underscores the value that state partnerships add to NOAA Office of Law Enforcement’s ability to complete its mission,” said Assistant Director Logan Gregory for NOAA Fisheries Office of Law Enforcement. “In this case, our partnership with New Jersey Division of Fish and Wildlife was crucial in protecting the oyster resource in New Jersey and leveling the playing field across multiple industry sectors throughout the mid-Atlantic Region.”

The Lacey Act prohibits creating or submitting false records for fish or wildlife moving in interstate commerce and also prohibits trafficking in fish or wildlife known to be illegally taken or possessed. The FDA and state health agencies require that oyster purchasers and sellers maintain accurate records of the amounts and locations of oyster harvest for all oysters they buy and sell in order to protect public health and minimize the impact of any oyster-borne outbreak of disease.

The case was investigated by the NOAA Office of Law Enforcement and the New Jersey Department of Environmental Protection’s Division of Fish and Wildlife. The case was prosecuted by Assistant Chief Wayne D. Hettenbach and Trial Attorney Patrick M. Duggan of the Environment and Natural Resources Division’s Environmental Crimes Section, with assistance from Assistant U.S. Attorney Matthew T. Smith of the U.S. Attorney’s Office for the District of New Jersey.

Tuesday, January 20, 2015

DOJ ANNOUNCES COURT INJUNCTION AGAINST MEDICAL LASER MANUFACTURER

FROM: U.S. JUSTICE DEPARTMENT
Friday, January 16, 2015
Federal Court Issues Preliminary Injunction Against South Dakota Medical laser Manufacturer

A federal court has barred a Rapid City, South Dakota, company and its president from further manufacturing and distributing its laser devices, which they marketed to treat a variety of medical conditions and diseases, the Justice Department announced today.

U.S. District Court Chief Judge Jeffrey L. Viken for the District of South Dakota entered the preliminary injunction on Wednesday against Robert “Larry” Lytle and his businesses, QLasers PMA, 2035 PMA, and 2035 INC., in an action filed by the Justice Department to enforce provisions of the federal Food, Drug, and Cosmetic Act (FDCA). The court’s order prohibiting the manufacture and distribution of the QLaser devices also applies to Lytle’s business affiliates and franchisees.

Last October, the Justice Department and the U.S. Attorney’s Office for the District of South Dakota filed a civil complaint for injunctive relief against Lytle and his businesses, alleging that they have been violating the FDCA by nationally marketing Lytle’s laser devices for the treatment of more than 200 different diseases and medical disorders without clearance or approval from the U.S. Food and Drug Administration (FDA). The preliminary injunction entered on Wednesday takes effect immediately and will remain in force while the government’s case seeking a permanent injunction proceeds to final judgment.

Judge Viken found, based on what he called an “extensive and well developed record,” that Lytle and his various businesses “have shown no intent to discontinue their activities and voluntarily comply with the FDCA. “The injunction bars the defendants from continuing to market and distribute any medical devices until they receive written permission from the FDA to do so.

Lytle, whom the court noted was a dentist in Rapid City until his license to practice dentistry was permanently revoked by the South Dakota Board of Dentistry in 1998, markets the devices by soliciting purchasers to join his “private membership associations” or “PMAs” before purchasing his lasers. As the court explained, however, “Hiding behind a curtain of private membership associations, 2035 PMA and QLaser PMA, does not shield Mr. Lytle from the authority of the FDCA or the jurisdiction of the court.”

“With the entry of this preliminary injunction, we have taken another step toward ensuring that only medical devices that have been shown to be safe and effective are placed in the hands of the American consumer,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division. “Everyone who deals in products that affect people’s health must comply with the FDCA.”

According to court documents filed in the case, the defendants have been distributing the QLaser devices with labeling that contains false and misleading claims, touting their use in treating such serious conditions as cancer, HIV/AIDS, venereal disease and diabetes. Although two of his laser devices were FDA-cleared for providing temporary relief of pain associated with osteoarthritis of the hand, none of the devices has been cleared or approved to treat any other medical conditions. The government alleges that not only are there no published clinical studies to support the use of Lytle’s lasers to treat other serious medical conditions, but that in fact, using the devices according to the device’s labeling could be dangerous to health. The court’s order finds that the United States is substantially likely to succeed on the merits on this claim and the others within the government’s complaint.

“The preliminary injunction granted should provide consumers a renewed sense of confidence,” said U.S. Attorney Brendan V. Johnson for the District of South Dakota. “This action is crucial to prevent the company from continuing to operate on the periphery of the law, and potentially jeopardize the health and safety of its consumers.”

The FDA referred this enforcement action to the Department of Justice. The government’s case is being litigated by Trial Attorney Ross S. Goldstein of the Civil Division’s Consumer Protection Branch, with assistance from the U.S. Attorney’s Office for the District of South Dakota and the FDA’s Office of Chief Counsel.

Saturday, December 20, 2014

FDA APPROVES VIEKIRA PAK FOR TREATMENT OF HEPATITIS C

FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA approves Viekira Pak to treat hepatitis C

The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.

Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).

“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”

Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.

Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.

The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily.

The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.

Viekira Pak is the eleventh new drug product with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Viekira Pak was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Viekira Pak is marketed by AbbVie Inc., based in North Chicago, Illinois. Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals. Sovaldi and Harvoni are marketed by Gilead Sciences, based in Foster City, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Wednesday, November 26, 2014

U.S. ACCUSES SANDWICH CO. OF DISTRIBUTING FOOD MADE IN INSANITARY CONDITIONS

FROM: U.S. JUSTICE DEPARTMENT
Friday, November 21, 2014
United States Files Enforcement Action Against Michigan Sandwich Company and Co-Owner to Stop Distribution of Adulterated Products

A civil complaint was filed in federal court in Michigan against Scotty’s Incorporated of Detroit and its co-owner and manager, Sandra Jackson, to prevent the distribution of adulterated sandwiches, the Department of Justice announced today.

According to the complaint, Scotty’s Incorporated, which does business as Bruce Enterprises and Bruce’s Fresh Products, prepares and distributes ready-to-eat (RTE) sandwiches, including RTE tuna sandwiches. The complaint alleges that the company’s sandwiches are manufactured in insanitary conditions, and that the company’s procedures are inadequate to ensure the safety of its products. Moreover, the company has failed to implement a written Hazard Analysis and Critical Control Point (HACCP) plan for handling seafood and minimizing the potential for harmful contamination in the company’s RTE tuna sandwiches. The Justice Department filed the injunction action in the Eastern District of Michigan at the request of the U.S. Food and Drug Administration (FDA).

“Seafood poses well-known risks when it is transported from ship to shore, but these risks can be effectively mitigated if companies handling seafood take proper precautions,” said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division. “The Department of Justice will take all appropriate measures to protect the safety of the seafood consumers eat.”

According to the complaint, the FDA has performed five inspections of the defendants’ facility since 2006 and documented insanitary practices and/or seafood HACCP violations every time. These inspections revealed that the company’s RTE sandwiches are adulterated within the meaning of the Food, Drug, and Cosmetic Act because they are prepared, packed or held under insanitary conditions in which they may have become contaminated with filth or rendered injurious to health. The complaint alleges, for example, that since 2006, the company was repeatedly told to develop a written HACCP plan recognizing the inherent risks of toxin formation in tuna and enumerating plans to take corrective action when tuna is not properly handled.

Tuna that is not chilled rapidly or stored at sufficiently lower temperatures is at increased risk for the formation of scombrotoxin. The toxin can be adequately controlled when tuna is chilled after death and maintained at a cold temperature throughout storage and distribution. In the event that the tuna is not properly maintained, scombrotoxin readily forms and cannot be removed or destroyed through subsequent washing, freezing or cooking of the tuna. Consumption of fish containing high levels of scombrotoxin may cause scombrotoxin poisoning, the symptoms of which may include burning sensations in the mouth or throat, dizziness, nausea, vomiting, headaches, diarrhea, rashes, hives, a drop in blood pressure, constriction of the air passage, heart palpitations and respiratory distress.

According to the complaint, the FDA’s most recent inspection was conducted between January 14 and February 6. At the inspection, according to the complaint, the FDA found that the defendants failed to have and implement an HACCP plan for food safety hazards reasonably likely to occur. There were also no sanitation control records documenting the safety of, among other things, water used at the facility; the cleanliness of surfaces, utensils and equipment coming into contact with food; maintenance of hand-sanitizing machines and bathrooms; exclusion of pests from the facility; and control of employee health conditions such as the wearing of jewelry, hair nets or beard covers.

The government is represented by Trial Attorney Dan Baeza of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Peter Caplan of the Eastern District of Michigan, with the assistance of Assistant Chief Counsel for Enforcement Christopher Fanelli of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.

Saturday, August 30, 2014

FDA COMPLETES REVIEW OF HOW AGENCY EVALUATES HARMFUL CHEMICALS IN PRODUCTS

FROM: U.S. FOOD AND DRUG ADMINISTRATION

FDA Takes Steps to Strengthen Program to Assess the Safety of Chemicals in Foods, Other Products

August 28, 2014

The U.S. Food and Drug Administration has completed a review of how the agency evaluates the harmful effects of chemicals in foods, cosmetics, dietary supplements, animal food/feed and veterinary drugs. Based on the findings, the agency is taking steps to strengthen internal processes.

The chemical safety assessment review is the first of three planned strategic reviews being conducted under the direction of the FDA’s Office of Foods and Veterinary Medicine (OFVM). The other two focus on nutrition and microbiological laboratory programs.

The FDA conducted the chemical safety assessment review in order to ensure that the agency is making the most effective and efficient use of its chemical safety resources. The review focused on the scientific capacity and management of the program’s multiple elements across the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Initiated in 2012, the review included interviews of current and former FDA employees involved in all aspects of the agency’s chemical safety assessment program, as well as senior managers from other U.S. government agencies experienced in chemical safety assessment, and five listening sessions conducted by CFSAN with internal and external stakeholders on OFVM’s overall chemical safety assessment program. In addition, four outside consultants, all of whom are considered experts in the field, and who had previously held senior management positions dealing with chemical safety assessment in the Federal government, met with OFVM and senior CFSAN managers to discuss the interview and listening session reports. Based on this discussion and their review of the interview and listening session reports, each consultant also made his or her own written recommendations for OFVM’s chemical safety program.

Working groups were formed in CFSAN and CVM to review all the reports and consultant recommendations. The issues and recommendations identified in the workgroup reports fall into three overarching categories (Science, Communication and Collaboration, and Training and Expertise).

Among the review’s most significant outcomes: the centers, led by CFSAN, will develop a process for updating FDA’s Toxicological Principles for the Safety Assessment of Food Ingredients (also called the “Redbook”), so that it reflects current science. Additionally, the centers will jointly develop a process to ensure consistency of methodologies used for safety and risk assessments within and across offices at CFSAN, and between CFSAN and CVM.

Saturday, August 16, 2014

FDA APPROVES AVASTIN FOR TREATMENT IN SOME PATIENTS WITH CERVICAL CANCER

FROM: U.S. FOOD AND DRUG ADMINISTRATION

FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer

The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.

Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA’s priority review program, demonstrating the agency’s commitment to making promising therapies available to patients faster.”

The FDA reviewed Avastin for treatment of patients with cervical cancer under its priority review program because the drug demonstrated the potential to be a significant improvement in safety or effectiveness over available therapy in the treatment of a serious condition. Priority review provides an expedited review of a drug’s application.

The safety and effectiveness of Avastin for treatment of patients with cervical cancer was evaluated in a clinical study involving 452 participants with persistent, recurrent, or late-stage disease. Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.

The most common side effects associated with use of Avastin in patients with cervical cancer include fatigue, decreased appetite, high blood pressure (hypertension), increased glucose in the blood (hyperglycemia), decreased magnesium in the blood (hypomagnesemia), urinary tract infection, headache and decreased weight. Perforations of the gastrointestinal tract and abnormal openings between the gastrointestinal tract and vagina (enterovaginal fistula) also were observed in Avastin-treated patients.

Avastin is marketed by South San Francisco, California-based Genentech, a member of the Roche Group.

Wednesday, August 13, 2014

COMPLAINT FILED AGAINST MICHIGAN CHEESE FACTORY FOR DISTRIBUTING ADULTERATED CHEESE PRODUCTS

FROM: U.S. JUSTICE DEPARTMENT

Friday, August 8, 2014

United States Files Enforcement Action Against Michigan Cheese Company and Owners to Stop Distribution of Adulterated Cheese Products

A civil complaint was filed today in federal court in Michigan against S. Serra Cheese Company of Clinton Township, Michigan, and its owners, Stefano and Fina Serra, to prevent the distribution of adulterated cheese, announced Assistant Attorney General Stuart F. Delery of the Justice Department’s Civil Division.

S. Serra Cheese Company manufactures and distributes several varieties of Italian cheeses, such as ricotta, provolone, mozzarella and primo sale. The complaint alleges that the company’s Italian cheeses are manufactured in insanitary conditions, and that the company’s procedures are inadequate to ensure the safety of its products. The department filed the injunction action in the Eastern District of Michigan at the request of the U.S. Food and Drug Administration (FDA).

“The presence of potentially harmful pathogens in food and processing facilities poses a serious risk to the public health,” said Assistant Attorney General Delery. “The Department of Justice will continue to bring enforcement actions against food manufacturers who do not follow the necessary procedures to comply with food safety laws.”

According to the complaint, two FDA inspections performed in 2013 revealed that the company’s cheese is adulterated within the meaning of the Food, Drug and Cosmetic Act because it is prepared, packed or held under insanitary conditions in which it may have become contaminated with filth or rendered injurious to health. The complaint alleges, for example, that the company repeatedly failed to reduce the risk of contamination from two potentially dangerous types of bacteria: Escherichia coli (E. coli) and Listeria innocua (L. innocua).

Although the strains of E. coli found in cheese samples collected from the company’s facility were n on-pathogenic, their presence indicates that the facility is insanitary and contaminated with filth. In addition, t he presence of L. innocua indicates insanitary conditions and a work environment that could support the growth of L. monocytogenes, an organism that poses a life-threatening health hazard because it is the causal agent for the disease listeriosis, a serious encephalitic disease. The presence of L. innocua in the company’s facility demonstrates the potential for the presence of L. monocytogenes in the same processing environment.

According to the complaint, the FDA’s most recent inspection in November 2013 revealed insanitary conditions, including the presence of generic, non-pathogenic E. coli and L. innocua and the absence of effective monitoring and sanitation controls in accordance with the current Good Manufacturing Practice requirements for food under federal law. For example, cleaning and sanitizing operations for utensils and equipment were not performed in a manner that protects against contamination of food and food contact surfaces.

FDA previously inspected the facility in January 2013. According to the complaint, at that time, FDA inspectors discovered a number of Good Manufacturing Practice deficiencies. For example, FDA inspectors noted that the facility was not constructed in such a manner as to allow floors to be adequately cleaned and to be kept clean and in good repair. The FDA inspectors also observed that the company failed to store raw materials in a manner that protects against contamination.

The government is represented by Trial Attorney Dan Baeza of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Peter Caplan for the Eastern District of Michigan, with the assistance of Assistant Chief Counsel for Enforcement Christopher Fanelli of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services.

A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.

Friday, July 25, 2014

AN EXTENDED-RELEASE OXYCODONE WITH ABUSE-DETERRENT PROPERTIES APPROVED BY FDA

FROM: U.S. FOOD AND DRUG ADMINISTRATION

FDA approves new extended-release oxycodone with abuse-deterrent properties

July 23, 2014

Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistentwith the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death.

"The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” said Sharon Hertz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”

Targiniq ER is not approved, and should not be used, for as-needed pain relief. Given Targiniq ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management.

The safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain. The safety database supporting approval included treatment of more than 3,000 people with Targiniq ER. Data from in vitro (in a laboratory) and in vivo (testing with people) abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse (snorting, injecting). The most common side effects of Targiniq ER are nausea and vomiting.

The FDA is requiring postmarketing studies of Targiniq ER, to assess the serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long term use beyond 12 weeks. The FDA is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER.

In addition, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.

Targiniq ER is manufactured by Stamford-based Purdue Pharma L.P.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Thursday, July 10, 2014

FDA APPROVES MEDTRONIC COREVALVE SYSTEM

FROM: U.S. FOOD AND DRUG ADMINISTRATION

Medtronic CoreValve System - P130021/S002

Wednesday, June 4, 2014

FDA REPORTS ON MAMMOGRAPHY QUALITY STANDARDS ACT

MQSA National Statistics

FROM: U.S. FOOD AND DRUG ADMINISTRATION

MQSA National Statistics

In this section of the MQSA Scorecard, we present the most commonly requested national statistics regarding the MQSA program. These statistics are updated on the first of each month.

Certified facilities, as of October 1, 2013 8,691

Certification statistics, as of June 1, 2014

Total certified facilities / Total accredited units 8,714 / 13,523

Certified facilities with FFDM2 units / Accredited FFDM units 8,154 / 12,790

FY 2014 inspection statistics, as of June 1, 2014

Facilities inspected 5,323

Total units at inspected facilities 7,947

Percent of inspections where the highest noncompliance was a:

Level 1 violation 0.3%

Level 2 violation 11.4%

Level 3 violation 1.4%

Percent of inspections with no violation 86.9%

Total annual mammography procedures reported, as of June 1, 20141 38,747,608

1 This number is an aggregate of the total number of procedures performed annually as reported by facilities to their accreditation bodies. Facilities are asked to disclose this information at their initial accreditation, and then at the time of their re-accreditation, which takes place once every three years. FDA began collecting these data in 1998. The aggregate does not reflect the current number of procedures performed at these facilities, but only the numbers reported by them during the three-year period prior to the current date. We have aggregated only the numbers reported by certified, non-Veterans Administration facilities.

2 FFDM - Full Field Digital Mammography unit.

Sunday, June 1, 2014

GENERIC CELEBREX APPROVED BY FDA FOR ARTHRITIS, OSTEOARTHRITIS

FROM: U.S. FOOD AND DRUG ADMINISTRATION

FDA approves first generic versions of celecoxib

May 30, 2014

Release

The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Celecoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs.

In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Information about the availability of generic celecoxib can be obtained from the companies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Sunday, May 11, 2014

FDA APPROVES USE OF CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P) AND DEFIBRILLATORS (CRT-D)

FROM: U.S. FOOD AND DRUG ADMINISTRATION

Medtronic CRT-P and CRT-D Devices - P010015/S205 and P010031/S381

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Products Name: This approval is for the following Cardiac Resynchronization Therapy Pacemakers (CRT-P) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) devices:Medtronic, Inc.
Address: 8200 Coral Sea Street
Mounds View, MN 55112
Approval Date: April 10, 2014
Approval Letters: http://www.accessdata.fda.gov/ cdrh_docs/pdf/P100015S205a.pdf and http://www.accessdata.fda.gov/cdrh_docs/
pdf/P010031S381a.pdf
Consulta® CRT-P Model C4TR01
Syncra® CRT-P Model C2TR01

Consulta CRT-D Model D224TRK and D204TRM
Maximo II CRT-D Model D284TRK and D264TRM
Concerto II CRT-D Model D274TRK
Protecta XT CRT-D Model D314TRG and D314TRM
Protecta CRT-D Model D334TRG and D334TRM
Viva XT CRT-D Model DTBA1D1 and DTBA1D4
Viva S CRT-D Model DTBB1D1 and Model DTBB1D4
Brava CRT-D Model DTBC1D1 and DTBC1D4

What is it?

A Cardiac Resynchronization Therapy disclaimer icon (CRT) device is a special pacemaker designed to treat symptoms of heart failure by sending specially timed electrical impulses to improve the timing, or resynchronize pumping action of the heart's lower chambers (right and left ventricles). This improved timing can help control symptoms from heart failure.

There are two types of implantable CRT devices: one that is only a pacemaker (CRT-P) and the other that is a combination of a pacemaker and defibrillator (CRT-D). Defibrillators can shock the heart rhythm back to normal should dangerously fast rhythms occur.

Each CRT device consists of a pulse generator (containing a battery and electronic circuitry) connected to insulated wires called leads that deliver electrical impulses to stimulate the heart. The synchronizing leads include a right ventricular lead (RV) and a left ventricular (LV) lead.

A CRT-D combination pacemaker and defibrillator has added features and ability so it is able to detect and treat dangerously fast heart rhythms. Only some individuals with a damaged heart muscle are likely enough to develop dangerous heart rhythms to need a defibrillator. A physician can determine whether a CRT-P or CRT-D device is most appropriate.

How does it work? Both CRT-P and CRT-D devices resynchronize the heart action by providing electrical impulses to improve timing of the right and left sides of the heart using RV and LV leads. The leads also carry signals from the heart to the device. The timing of the impulses is programmed by the doctor to restore a more natural timing and pumping of the heart muscle which can improve heart failure. The RV leads of CRT-D devices have additional features to deliver high voltage energy to defibrillate the heart should life-threatening, dangerously fast rhythms occur in the ventricles (ventricular arrhythmia) disclaimer icon .

When is it used? CRT-P and CRT-D devices have been approved for many years for patients with poorly synchronized right and left ventricles to improve their heart failure symptoms. Based on the results of a new clinical study called BLOCK HF, FDA is now expanding who is eligible (or “indicated”) for CRT. The new, added patients must have EACH of the following:

MUST have slow or absent ventricular heart beating (heart block) with symptoms that would traditionally require a conventional pacemaker PLUS mild to moderate heart failure symptoms PLUS at least mild heart muscle damage The actual specific indications appear below. After evaluating a patient’s degree of heart damage and heart failure symptoms, a doctor can determine whether they fit the new BLOCK HF indication and would benefit from CRT.
CRT-P Device Indications:

Previously Approved by FDA:

Patients with moderate to severe heart failure symptoms (NYHA Functional Class III and IV) despite stable, optimal heart failure medical therapy
PLUS severe heart damage (cardiac ejection fraction [LVEF] less than or equal to 35%) PLUS electrocardiogram (EKG) signs of poor synchronization of the ventricles

New BLOCK HF Indication:

slow or absent ventricular heart beating (atrioventricular block [AV block] expected to require a high percentage of ventricular pacing that would traditionally require a conventional pacemaker PLUS mild to moderate heart failure symptoms (NYHA Functional Class I, II or III) PLUS at least mild heart muscle damage (cardiac ejection fraction [LVEF] less than or equal to 50%)

NOTE: heart failure medications must be optimized after the device is implanted.
CRT-D Device Indications:

Previously Approved by FDA:

The primary use of a CRT-D system is for automated treatment of life-threatening ventricular arrhythmias. They also provide CRT in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following heart failure classifications:

Patients with moderate to severe heart failure symptoms (NYHA Functional Class III and IV)

PLUS severe heart damage (cardiac ejection fraction [LVEF] less than or equal to 35%)

PLUS EKG signs of poor synchronization of the ventricles

OR

Patients with mild to moderate heart failure symptoms (NYHA Functional Class II)

PLUS EKG signs of very poor synchronization of the ventricles (Left bundle branch block (LBBB) with a ventricular stimulation time greater than or equal to130 ms)

PLUS severe heart damage (cardiac ejection fraction [LVEF] less than or equal to 30%)

New BLOCK HF CRT-D Indication:
The primary use of a CRT-D system is for automated treatment of life-threatening ventricular arrhythmias. They also provide CRT in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following heart failure classifications: slow or absent ventricular heart beating (atrioventricular block [AV block] expected to require a high percentage of ventricular pacing that would traditionally require a conventional pacemaker PLUS mild to moderate heart failure symptoms (NYHA Functional Class I, II or III)

PLUS at least mild heart muscle damage (cardiac ejection fraction [LVEF] less than or equal to 50%)

NOTE: heart failure medications must be optimized after the device is implanted.
What will it accomplish? Based on the results of the BLOCK HF clinical study, when used in the new population as described above, patients may benefit by experiencing less frequent heart failure worsening or need for urgent treatment.
When should it not be used? The contraindications for the CRT-P and CRT-D devices are listed below.

CRT-P Devices:

implantation with another bradycardia device
implantation with an implantable cardioverter defibrillator
There are no known contraindications for the use of pacing as a therapy to control heart rate. The patient’s age and medical condition, however, may determine the particular pacing system, mode of operation, and implant procedure used by the doctor.

automatic adjustment of pacing rate may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate.

Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter.
Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms.

Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance.

Anti-tachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathwayCRT-D Devices:

Patients experiencing tachyarrhythmia with transient or reversible causes including, but not limited to, the following: heart attack (acute myocardial infarction), drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia disclaimer icon , or sepsis.

Patients who have a unipolar pacemaker implanted.
Patients with continuous ventricular tachycardia (VT) or ventricular fibrillation (VF).

Patients whose primary disorder is chronic atrial tachyarrhythmia in the absence of VT or VF. (NOTE: This contraindication does not apply to the Maximo II devices).

Friday, April 25, 2014

FDA POINTS OUT SEVERAL TYPES OF TOBACCO PRODUCTS

FROM: FEDERAL FOOD AND DRUG ADMINISTRATION
Recognize Tobacco in its Many Forms

Tobacco use is the single largest preventable cause of disease and death in the United States, but can you recognize all the different forms of a tobacco product? The marketplace includes an array of new products, with many looking very different from the traditional tobacco products you may know about.
To attract users, tobacco companies regularly modify their products and introduce novel tobacco products to the market. “Parents should stay updated on the various products available and, discuss the dangers of tobacco use with their children,” says Ii-Lun Chen, M.D., a pediatrician and medical branch chief in the Office of Science at FDA’s Center for Tobacco Products.

The basic components of most cigarettes are tobacco, a filter, and paper wrapping. Although smokers use cigarettes to get nicotine, they are exposed to toxic and cancer-causing chemicals that are created when the cigarette is burned.

Cigars, Little Cigars, Cigarillos

Generally, cigars are cured tobacco wrapped in leaf tobacco or a substance containing tobacco. Cigars vary in size — with smaller sizes sometimes referred to as little cigars or cigarillos. Large cigars can deliver as much as 10 times the nicotine, 2 times more tar, and more than 5 times the carbon monoxide than a filtered cigarette. Although cigarettes with characterizing flavors are illegal, there are products available on the market that look like cigarettes but are labeled as “little cigars,” and some include candy and fruit flavors that appeal to adolescents and youth adults. Cigars also may appeal to youth because they may be less expensive than cigarettes. In addition, young adults may think that cigars are less addictive and present fewer health risks than cigarettes.

Dissolvable Products

In the past, smokeless tobacco products have required spitting or discarding the product remains. There are new tobacco products that are not smoked and are often called “dissolvables.” These products can be more easily concealed as no product disposal is needed. They are sold as lozenges, strips, or sticks, and may look like candy. The advertised appealing flavor and discreet forms of these products may encourage young people to take them up, but the nicotine content can lead to addiction and may also present an accidental poisoning risk for children.

Electronic Cigarettes (Also Referred to as: Vape Pen, e-Hookah, Hookah Pen)

Electronic cigarettes often resemble traditional cigarettes but they use a heat source, usually powered by a battery, to turn “e-liquid,” a liquid that usually contains nicotine from tobacco and flavorings, into an aerosol that is inhaled by the user. The amount of nicotine in the aerosol may vary by brand. Little information about the safety of electronic cigarettes exists.

Traditional Smokeless Tobacco Products

There are two main types of smokeless tobacco that have been traditionally marketed in the United States: chewing tobacco and moist snuff. Chewing tobacco is cured tobacco in the form of loose leaf, plug, or twist. Snuff is finely cut or powdered, cured tobacco that can be dry, moist, or packaged in sachets. Snus is a finely ground moist snuff that can be loose or packaged. Most smokeless tobacco use involves placing the product between the cheek or lip and the gum.

The availability of flavored, lower-nicotine, smokeless tobacco products lacking harsh attributes promoted by manufacturers may allow for experimentation by new users, but may also lead to nicotine addiction and continued use of smokeless or other tobacco products. Over time, smokeless tobacco users may switch from lower-nicotine smokeless tobacco products to products that deliver more nicotine.

Waterpipes (Also Referred to as: Hookah, Shisha, Narghile, Argileh)

Waterpipes (also known as hookah, shisha, narghile, or argileh) are used to smoke specially made tobacco that comes in a variety of flavors like mint, cherry and licorice. Waterpipe smoking delivers the addictive drug nicotine and the smoke from a waterpipe is at least as toxic as, or more toxic than cigarette smoke. In fact, research shows that waterpipe smokers may absorb even more of the harmful components found in cigarette smoke because smoking sessions are longer. A typical one-hour hookah session involves inhaling 100â€“200 times the volume of smoke from a single cigarette. Waterpipe tobacco flavoring, exotic paraphernalia, and social use at hookah bars have increased its popularity with people who don’t already smoke cigarettes and younger people in the United States.

What FDA Currently Regulates

Currently, FDA regulates the manufacture, marketing and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, FDA has recently issued a proposed rule to bring additional products that meet the Tobacco Control Act’s definition of a tobacco product under FDA’s regulatory authority, including electronic cigarettes, some or all cigars, pipe tobacco, dissolvables, and waterpipe tobacco. The proposed rule will be available for public comment for 75 days and FDA encourages the public to submit comments, data, research, or other information related to the proposed rule.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

April 24, 2014

Thursday, April 24, 2014

FDA TOUTS ADULT STEM CELL RESEARCH

FROM: U.S. FOOD AND DRUG ADMINISTRATION

Adult Stem Cell Research Shows Promise

So What Are Stem Cells?

Why Is FDA Studying These Cells?

What's Being Done?

Scientists sporting white coats and safety gloves are working in a bright Food and Drug Administration (FDA) lab on an incredible project.

They are part of FDA’s MSC Consortium, a large team of FDA scientists studying adult mesenchymal stem cells (MSCs)—cells that could eventually be used to repair, replace, restore or regenerate cells in the body, including those needed for heart and bone repair.

The scientists’ investigational work is unprecedented: Seven labs at FDA's Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function.

“This research aims to facilitate development of this important class of innovative medical products,” explains Carolyn A. Wilson, Ph.D., associate director for research at the center. “It’s the first time we’ve done anything like this, and it’s proven to be a very useful approach. It’s worked so well because this is a huge, complicated project that requires expertise in many different technologies and methods.”

The research could ultimately be key to the advancement of personalized medicine, the practice in which medical treatment is tailored to the needs of an individual patient. “It’s not science fiction,” says Steven R. Bauer, Ph.D., chief of the Cellular and Tissue Therapy Branch in FDA’s Office of Cellular Tissue and Gene Therapies. “For me, regenerative medicine is the most exciting part of what we regulate in our office.”

So What Are Stem Cells?
There are two basic kinds of stem cells that are currently useful in the field of regenerative medicine: multipotent and pluripotent stem cells. Multipotent stem cells are generally taken from adults and can divide and develop into many different cell types. Pluripotent stem cells can develop into any type of cell in the body. Both types could divide to replenish cells damaged by injury, illness or normal wear. When stem cells divide, the new cells can either remain stem cells or develop into a new type of cell with a more specific function.
Two types of pluripotent stem cells exist: human embryonic stem cells and induced pluripotent stem cells, which are created by reprogramming adult cells that had already changed into a mature type of cell.

FDA’s MSC Consortium is not studying stem cells taken from embryos. “We’re looking at a particular kind of multipotent adult stem cell—the MSC—which is being used in a lot of regenerative medicine clinical trials,” adds Bauer.

The group is currently studying eight unique cell lines, each acquired from commercial sources and sourced to one of eight distinct, adult donors. (Males and females age 22 to 47 donated stem cells from bone marrow.)

The cells under study are multipotent: “They can differentiate (mature into) at least three cell types: bone, fat and cartilage, primarily,” Bauer explains. “They can also differentiate into nerve cells, liver cells and a kind of cell called ‘stroma’ that is in the bone marrow and supports blood forming cells. Then, for investigational clinical uses, they’ve been used for repairing hearts, repairing bone and repairing cartilage.”

Why Is FDA Studying These Cells?
In addition to differentiating into a variety of replacement cell types, MSCs can limit a patient’s immune response. So they can potentially be taken from one human donor and placed into a different recipient with less possibility of rejection.

But growing stem cells and making sure they are safe and effective is challenging, which is one reason why stem-cell based clinical trials have not yet resulted in a marketed product.

“The major challenge is that cells are much more complex than traditional products that FDA regulates. And they have the ability to respond to their environment,” Bauer explains. “Taking them out of the body and manufacturing them—that is, growing large numbers of them—or isolating them can change their biology. And it can change the way they behave if they are put back into the patient.”

For instance, if cells are manufactured in large quantities outside their natural environment, they may become ineffective or develop harmful characteristics. For example, they can produce tumors, severe immune reactions or growth of unwanted tissue. So FDA is trying to develop methods that would predict with more certainty how manufactured or isolated adult stem cells will behave in patients.

What's Being Done?
In the labs, cells are suspended in a nutrient liquid solution and grown in sterile containers called tissue culture flasks. Cells then multiply and go through three, five or seven generations of growth.
FDA scientists are using a variety of cutting-edge methods to characterize cells and then determine if any of these characteristics can predict the behavior of the cells in biological assays or in animal models. The next step will be to determine if any characteristics they measure will predict the safety or effectiveness of stem-cell based products in patients.

Specifically, scientists will continue studying whether factors such as different methods of growing the cells, donor age or gender affects the cells’ quality and performance. This research will ultimately provide new tools to the community of academic and private industry scientists who are interested in evaluating and developing stem cells into new clinical treatments.

“The consortium has shown that widely accepted ways to identify and characterize MSCs do not reveal some important biological differences between batches of these cells,” Bauer says. So the consortium seeks to demonstrate ways to better characterize MSCs that will be used in clinical trials. That’s important because, if investigators can improve the tools used to characterize MSCs used for clinical trials, the data generated from their studies could also improve because their MSC products will be more predictable, he adds.

And the improved predictability of their products will, in turn, allow FDA scientists to more easily evaluate the safety and effectiveness of new stem cell technologies—a key part of the regulatory science that is the foundation of FDA decisions.

Agency scientists already have published six papers in scientific journals such as Tissue Engineering and Cytotherapy. “We’re hoping this project will inspire people to do more research in this area,” Bauer says.

Stem cells, like other medical products intended to treat, cure or prevent disease, require FDA approval before they can be marketed. “It is important for FDA to maintain a sound regulatory science research program to promote the development of safe and effective products in emerging areas that hold great promise,” Bauer says.

“My colleagues and I hope our scientific findings will be helpful in the field of regenerative medicine, including the ability to repair or even replace organs and tissues more safely and effectively than traditional means,” he adds. “Although there are many scientific hurdles to overcome before the use of stem cells reaches its full potential, I think this medicine will eventually have the capacity to do that.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Wednesday, April 23, 2014

CYRAMZA APPROVED BY FDA FOR TREATMENT OF STOMACH CANCER

FROM: U.S. FOOD AND DRUG ADMINISTRATION

For Immediate Release: April 21, 2014

Consumer Inquiries: 888-INFO-FDA

FDA approves Cyramza for stomach cancer

The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

Stomach cancer forms in the tissues lining the stomach and mostly affects older adults. According to the National Cancer Institute, an estimated 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the disease, this year.

Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients whose cancer cannot be surgically removed (unresectable) or has spread (metastatic) after being treated with a fluoropyrimidine- or platinum-containing therapy.

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”

Cyramza’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo. The trial was designed to measure the length of time participants lived before death (overall survival).

Results showed participants treated with Cyramza experienced a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo. Additionally, participants who took Cyramza experienced a delay in tumor growth (progression-free survival) compared to participants who were given placebo. Results from a second clinical trial that evaluated the efficacy of Cyramza plus paclitaxel (another cancer drug) versus paclitaxel alone also showed an improvement in overall survival.

Common side effects experienced by Cyramza-treated participants during clinical testing include diarrhea and high blood pressure.

The FDA reviewed Cyramza under its priority review program, which provides an expedited review for drugs that have the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Cyramza was also granted orphan product designation because it is intended to treat a rare disease or condition.

Cyramza is marketed by Indianapolis-based Eli Lilly.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

FDA: Drug Innovation

NCI: Stomach Cancer

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Tuesday, April 22, 2014

FDA SCIENTIST WORKING TO CREATE DNA BAR-CODES TO IDENTIFY FISH SPECIES

FROM: U.S. FOOD AND DRUG ADMINISTRATION

Have you sometimes wondered if that "wild caught" salmon actually came from an aqua farm? Or if the "U.S. catfish" in the display case might have been born and raised in Vietnam?

Is that "red snapper" actually red snapper and worth the premium price?

Scientists at the Food and Drug Administration (FDA) are able to answer those questions through a project that creates DNA barcodes to identify individual fish species. The massive project is part of an effort aimed at solving the problem of species substitution.

Species substitution can result in cheap fish being labeled as pricy ones, but mislabeling can also threaten public health. For example, in 2007, a prohibited and highly toxic variety of puffer fish, also known as fugu or blowfish, was smuggled into the U.S. in boxes labeled as "headless monkfish." This deception resulted in illnesses in multiple states.

A series of cutting-edge tests must be conducted to create the barcodes, which look much like the lines of different thicknesses on Universal Product Code (UPC) labels used to identify and scan manufactured products. However, unlike the barcodes you see on packages in the supermarket, the barcodes that identify different fish species will not be attached to the fish.

Instead, once a fish species is identified through DNA testing and other high-tech techniques in FDA labs, the newly created barcode unique to that species is entered into a database, which could be thought of as a library or catalogue of commercial fish species.

When encountering a fish or fish product (fillets, fish sticks, sushi, etc.) whose species is unknown, inspectors with the equipment and know-how can create a barcode for that fish and compare it against FDA's database to seek a known match.

The agency has trained more than 20 FDA analysts around the country to use that procedure in many of its regional field laboratories and are now performing the analysis on a regular basis.

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NORTH SEA WITH BLOOMING PHYTOPLANKTON

Despite its cold waters and harsh winds, the North Sea is a fertile basin for phytoplankton blooms. The drifting, plantlike organisms tend to be most abundant in late spring and early summer due to high levels of nutrients in the water and increasing sunlight. The intense winds blowing over the relatively shallow North Sea causes a lot of vertical and horizontal mixing that brings nutrients to the surface, as does runoff from European rivers. This image, acquired on June 11, 2015, by the Moderate Resolution Imaging Spectroradiometer (MODIS) on NASA’s Aqua satellite, shows a mass of phytoplankton blooming between Denmark, the United Kingdom, and Germany. As compared to a June 6 image showing a different stage of the bloom cycle, areas of concentrated phytoplankton are smaller and most have the milky color characteristic of coccolithophores; there are few to no green areas. The change could be due to the short life span of phytoplankton—two to six days—and differences between the species. Some outlast others because of their ability to survive at lower nutrient levels. Some researchers have found that numbers of plankton can actually begin to increase in the middle of winter, when growth conditions would seem to be at their worst. Studies suggest that winter storms churn the ocean and cause deep water mixing. This water mixing allows for phytoplankton to grow and live at depth without being spotted by their predators. When spring arrives, phytoplankton can fully bloom because not only are the nutrients available, but there is a longer period of sunlight. Image Credit: NASA Earth Observatory images by Jesse Allen, using data from the Level 1 and Atmospheres Active Distribution System (LAADS). Caption: Rachel Carlowicz with Mike Carlowicz

WATCHING YOUNG STARS SPARKLE

While fireworks only last a short time here on Earth, a bundle of cosmic sparklers in a nearby cluster of stars will be going off for a very long time. NGC 1333 is a star cluster populated with many young stars that are less than 2 million years old, a blink of an eye in astronomical terms for stars like the Sun expected to burn for billions of years. To make a detailed study of the X-ray properties of young stars, a team of astronomers, led by Elaine Winston from the University of Exeter, analyzed both the Chandra X-ray data of NGC 1333, located about 780 light years from Earth, and of the Serpens cloud, a similar cluster of young stars about 1100 light years away. They then compared the two datasets with observations of the young stars in the Orion Nebula Cluster, perhaps the most-studied young star cluster in the Galaxy.The researchers found that the X-ray brightness of the stars in NGC 1333 and the Serpens cloud depends on the total brightness of the stars across the electromagnetic spectrum, as found in previous studies of other clusters. They also found that the X-ray brightness mainly depends on the size of the star. In other words, the bigger the stellar sparkler, the brighter it will glow in X-rays. Image credit: X-ray: NASA/CXC/SAO/S.Wolk et al; Optical: DSS & NOAO/AURA/NSF; Infrared: NASA/JPL-Caltech.

ARTIST GRAPHIC OF PLUTO'S OCCULATION

The Stratosphere Observatory for Infrared Astronomy (SOFIA) is a modified Boeing 747SP aircraft that makes celestial observations with its German-built 100-inch telescope. The telescope is enhanced to collect infrared radiation, and is able to detect energy at a wider range of wavelengths than any other ground-based or space telescope. SOFIA can fly anywhere in the world, and operates at altitudes up to 45,000 feet, putting the observatory above more than 99 percent of Earth's atmospheric water vapor that blocks infrared radiation from celestial objects. SOFIA is flying out of Christchurch, New Zealand, where its telescope can study celestial objects more easily observed from the Southern Hemisphere. Starting June 28 through the 29th, instruments on the plane will observe Pluto as it passes in front of a background star. Data returned from the observations will be provided to the New Horizon team who is preparing for Pluto's occultation, July 13 through the 15th. Image is an artist's conception of the Pluto occultation seen close-up, not a photo. Credits: NASA Graphic.

SHOOTING STARS IN SPACE

Caption Credit: NASA. Astronaut Ron Garan, Expedition 28 flight engineer, tweeted this image from the International Space Station in August, 2011 with the following caption: “What a `Shooting Star’ looks like from space, taken yesterday during Perseid Meteor Shower.” A special camera to record meteor showers will launch to the International Space Station aboard SpaceX's Dragon cargo craft, currently scheduled to launch on June 28, 2015, from Cape Canaveral Air Force Station, Florida. The Meteor investigation should be installed in the station’s Window Observational Research Facility by the end of July, enabling scientists to learn more about the composition and behavior of asteroids and comets that cross paths with Earth. The investigation's camera is programmed to record known major meteor showers during its two-year orbit and could spot unpredicted showers as well. Image Credit: NASA.

SUNSET ON MARS

Curiosity used its Mast Camera (Mastcam) to record the sunset during an evening of skywatching on April 15, 2015. The imaging was done between dust storms, but some dust remained suspended high in the atmosphere. The sunset observations help researchers assess the vertical distribution of dust in the atmosphere. "The colors come from the fact that the very fine dust is the right size so that blue light penetrates the atmosphere slightly more efficiently," said Mark Lemmon of Texas A&M University, College Station, the Curiosity science-team member who planned the observations. "When the blue light scatters off the dust, it stays closer to the direction of the sun than light of other colors does. The rest of the sky is yellow to orange, as yellow and red light scatter all over the sky instead of being absorbed or staying close to the sun." Just as colors are made more dramatic in sunsets on Earth, Martian sunsets make the blue near the sun's part of the sky much more prominent, while normal daylight makes the rusty color of the dust more prominent. Photo/Caption Credit: NASA.

AN IMPACT LEFT ON MARS

The High Resolution Imaging Science Experiment (HiRISE) camera aboard NASA's Mars Reconnaissance Orbiter acquired this closeup image of a "fresh" (on a geological scale, though quite old on a human scale) impact crater in the Sirenum Fossae region of Mars on March 30, 2015. This impact crater appears relatively recent as it has a sharp rim and well-preserved ejecta. The steep inner slopes are carved by gullies and include possible recurring slope lineae on the equator-facing slopes. Fresh craters often have steep, active slopes, so the HiRISE team is monitoring this crater for changes over time. The bedrock lithology is also diverse. The crater is a little more than 1-kilometer wide. Image Credit: NASA/JPL/University of Arizona. Caption: Alfred McEwen.

A LOOK AT GALAXY NSG 6503

Caption Credit: NASA.Most galaxies are clumped together in groups or clusters. A neighboring galaxy is never far away. But this galaxy, known as NGC 6503, has found itself in a lonely position, at the edge of a strangely empty patch of space called the Local Void. The Local Void is a huge stretch of space that is at least 150 million light-years across. It seems completely empty of stars or galaxies. The galaxy’s odd location on the edge of this never-land led stargazer Stephen James O’Meara to dub it the “Lost-In-Space galaxy” in his 2007 book, Hidden Treasures. NGC 6503 is 18 million light-years away from us in the northern circumpolar constellation of Draco. NGC 6503 spans some 30,000 light-years, about a third of the size of the Milky Way. This Hubble Space Telescope image shows NGC 6503 in striking detail and with a rich set of colors. Bright red patches of gas can be seen scattered through its swirling spiral arms, mixed with bright blue regions that contain newly forming stars. Dark brown dust lanes snake across the galaxy’s bright arms and center, giving it a mottled appearance. The Hubble Advanced Camera for Surveys data for NGC 6503 were taken in April 2003, and the Wide Field Camera 3 data were taken in August 2013. The Hubble Space Telescope is a project of international cooperation between NASA and the European Space Agency. NASA’s Goddard Space Flight Center in Greenbelt, Maryland, manages the telescope. The Space Telescope Science Institute (STScI) in Baltimore conducts Hubble science operations. STScI is operated for NASA by the Association of Universities for Research in Astronomy, Inc., in Washington, D.C. Photo Credit: NASA, ESA, D. Calzetti (University of Massachusetts), H. Ford (Johns Hopkins University), and the Hubble Heritage Team.

FIRST AMERICAN WOMAN FLIES INTO SPACE ON SPACE SHUTTLE CHALLENGER

On June 18, 1983, Sally Ride became the first American woman to fly in space when the space shuttle Challenger launched on mission STS-7 from Pad 39A at NASA's Kennedy Space Center in Florida. The STS-7 crew consisted of astronauts Robert Crippen, commander, the first two-time space shuttle astronaut; Frederick H. Hauck, pilot; and three mission specialists -- Ride, John M. Fabian and Norman E. Thagard. This high-angle view of the shuttle liftoff, showing a lengthy stretch of Florida Atlantic coastline and a number of large cumulus clouds, was photographed with a handheld 70mm camera by astronaut John W. Young, who piloted the Shuttle Training Aircraft (STA) for weather monitoring at launch and landing sites for STS missions. One of Sally Ride's jobs was to call out "Roll program" seven seconds after launch. "I'll guarantee that those were the hardest words I ever had to get out of my mouth," she said later. Image Credit: NASA.

ON EDGE SPIRAL GALAXY NGC 5023

Caption Credit: NASA. This NASA/ESA Hubble Space Telescope image shows an edge-on view of the spiral galaxy NGC 5023. Due to its orientation we cannot appreciate its spiral arms, but we can admire the elegant profile of its disk. The galaxy lies over 30 million light-years away from us. NGC 5023 is part of the M51 group of galaxies. The brightest galaxy in this group is Messier 51, the Whirlpool Galaxy, which has been captured by Hubble many times. NGC 5023 is less fond of the limelight and seems rather unsociable in comparison — it is relatively isolated from the other galaxies in the group. Astronomers are particularly interested in the vertical structure of disks like these. By analyzing the structure above and below the central plane of the galaxy they can make progress in understanding galaxy evolution. Astronomers are able to analyze the distribution of different types of stars within the galaxy and their properties, in particular how well evolved they are on the Hertzsprung–Russell Diagram — a scatter graph of stars that shows their evolution. NGC 5023 is one of six edge-on spiral galaxies observed as part of a study using Hubble’s Advanced Camera for Surveys. They study this vertical distribution and find a trend which suggests that heating of the disc plays an important role in producing the stars seen away from the plane of the galaxy. In fact, NGC 5023 is pretty popular when it comes to astronomers, despite its unsociable behavior. The galaxy is also one of 14 disk galaxies that are part of the GHOSTS survey — a survey which uses Hubble data to study galaxy halos, outer disks and star clusters. It is the largest study to date of star populations in the outskirts of disk galaxies. The incredible sharp sight of Hubble has allowed scientist to count more than 30,000 individual bright stars in this image. This is only a small fraction of the several billion stars that this galaxy contains, but the others are too faint to detect individually even with Hubble. European Space Agency Credit-ESA-NASA

U.S. SAILORS RECOVER NASA TEST VEHICLE

A CROWDED NEIGHBORHOOD OF STARS

This NASA/ESA Hubble Space Telescope image presents the Arches Cluster, the densest known star cluster in the Milky Way. It is located about 25,000 light-years from Earth in the constellation of Sagittarius (The Archer), close to the heart of our galaxy, the Milky Way. It is, like its neighbor the Quintuplet Cluster, a fairly young astronomical object at between two and four million years old. The Arches cluster is so dense that in a region with a radius equal to the distance between the sun and its nearest star there would be over 100,000 stars! At least 150 stars within the cluster are among the brightest ever discovered in the Milky Way. These stars are so bright and massive that they will burn their fuel within a short time (on a cosmological scale that means just a few million years). Then they will die in spectacular supernova explosions. Due to the short lifetime of the stars in the cluster the gas between the stars contains an unusually high amount of heavier elements, which were produced by earlier generations of stars. Despite its brightness the Arches Cluster cannot be seen with the naked eye. The visible light from the cluster is completely obscured by gigantic clouds of dust in this region. To make the cluster visible astronomers have to use detectors which can collect light from the X-ray, infrared, and radio bands, as these wavelengths can pass through the dust clouds. This observation shows the Arches Cluster in the infrared and demonstrates the leap in Hubble’s performance since its 1999 image of same object. Image credit: NASA/ESA. Text credit: European Space Agency

SECOND TEST OF NASA'S LDSD

The second flight test of NASA's Low-Density Supersonic Decelerator (LDSD) will be attempted on Tuesday, June 2 at no earlier than 1:30 p.m. EDT (7:30 a.m. HST), launching a rocket-powered, saucer-shaped test vehicle into near-space from the Pacific Missile Range Facility on the island of Kauai in Hawaii. The LDSD project, led by the Jet Propulsion Laboratory in Pasadena, California, and sponsored by NASA’s Space Technology Mission Directorate in Washington, is conducting this full-scale flight test of two breakthrough technologies: a supersonic inflatable aerodynamic decelerator, or SIAD, and an innovative new parachute. These devices potentially will help us deliver double the current amount of payload — 1.5 metric tons — to the surface of Mars. They also will greatly increase the accessible surface area we can explore, and will improve landing accuracy from a margin of approximately 6.5 miles to a little more than 1 mile. All these factors will dramatically increase the success of future missions on Mars. The LDSD project's successful first flight test was launched on June 28, 2014. In this photograph, a full mission dress rehearsal is held for the LDSD project, Friday, May 29, 2015, at the U.S. Navy Pacific Missile Range Facility (PMRF) in Kauai, HI. Image Credit: NASA/Bill Ingalls

NASA SUPPORTS F-15 PROGRAM

NASA pilot Jim Less and photographer Jim Ross pull their F-15D #897 aircraft away from a KC-135 refueling tanker. NASA is supporting the Edwards Air Force Base F-15 program with safety and photo chase expertise. NASA Armstrong Flight Research Center currently flies an F-15D Eagle aircraft for research support and pilot proficiency. NASA research support aircraft are commonly called chase planes and fill the role of escort aircraft during research missions. Chase pilots are in constant radio contact with research pilots and serve as an "extra set of eyes" to help maintain total flight safety during specific tests and maneuvers. They monitor certain events for the research pilot and are an important safety feature on all research missions. Chase aircraft also are used as camera platforms for research missions that must be photographed or videotaped. Aeronautical engineers use this pictorial coverage (photos, motion pictures, and videotape) extensively to monitor and verify various aspects of research projects. The F-15D is also used by Armstrong research pilots for routine flight training required by all NASA pilots. Image Credit: NASA/Jim Ross.

SDO IMAGES OF THE SOLAR ATMOSPHEREE

Caption Credit: NASA. The Atmospheric Imaging Assembly (AIA) instrument aboard NASA's Solar Dynamics Observatory (SDO) images the solar atmosphere in multiple wavelengths to link changes in the surface to interior changes. Its data includes images of the sun in 10 wavelengths every 10 seconds. When AIA images are sharpened a bit, such as this AIA 171Å channel image, the magnetic field can be readily visualized through the bright, thin strands that are called "coronal loops". Loops are shown here in a blended overlay with the magnetic field as measured with SDO's Helioseismic and Magnetic Imager underneath. Blue and yellow represent the opposite polarities of the magnetic field. The combined images were taken on Oct. 24, 2014, at 23:50:37 UT. Image Credit: NASA SDO.

DEPRESSION ON SURFACE OF MARS

Caption Credit: NASA. This image of a circular depression on the surface of Mars was acquired on Jan. 5, 2015 by the High Resolution Imaging Science Experiment (HiRISE) camera on NASA's Mars Reconnaissance Orbiter (MRO). The spacecraft has been orbiting Mars since March 2006 and completed its 40,000th orbit around Mars on Feb. 7, 2015. The target of this observation is a circular depression in a dark-toned unit associated with a field of cones to the northeast. At the scale of an image taken by MRO's Context Camera, which provides wide area views to provide context for high-resolution analysis, the depression appears to expose layers especially on the sides or walls, which are overlain by dark sands presumably associated with the dark-toned unit. The HiRISE camera's resolution, which is far higher than that of the Context Camera and its larger footprint, can help identify possible layers. HiRISE is one of six instruments on the Mars Reconnaissance Orbiter. The University of Arizona, Tucson, operates HiRISE, which was built by Ball Aerospace & Technologies Corp., Boulder, Colo. NASA's Jet Propulsion Laboratory, a division of the California Institute of Technology in Pasadena, manages the Mars Reconnaissance Orbiter Project for NASA's Science Mission Directorate, Washington. Image Credit-NASA-JPL-Caltech-University of Arizona.

FLEET WEEK NEW YORK 2015

Caption Credit: U.S. Navy. 150520-N-PJ969-213 NEW YORK (May 20, 2015) The amphibious transport dock ship USS San Antonio (LPD 17) enters New York harbor during the Parade of Ships to start Fleet Week New York 2015. Fleet Week New York, now in its 27th year, is the city's time-honored celebration of the sea services. It is an unparalleled opportunity for the citizens of New York and the surrounding tri-state area to meet Sailors, Marines and Coast Guardsmen, as well as witness firsthand the latest capabilities of today's maritime services. (U.S. Navy photo by Mass Communication Specialist 2nd Class Abe McNatt/Released)

22,000 LIGHT YEARS TO EARTH: NGC 6535

This image captures the stunning NGC 6535, a globular cluster 22,000 light-years away in the constellation of Serpens (The Serpent) that measures one light-year across. Globular clusters are tightly bound groups of stars which orbit galaxies. The large mass in the rich stellar centre of the globular cluster pulls the stars inward to form a ball of stars. The word globulus, from which these clusters take their name, is Latin for small sphere. Globular clusters are generally very ancient objects formed around the same time as their host galaxy. To date, no new star formation has been observed within a globular cluster, which explains the abundance of aging yellow stars in this image, most of them containing very few heavy elements. NGC 6535 was first discovered in 1852 by English astronomer John Russell Hind. The cluster would have appeared to Hind as a small, faint smudge through his telescope. Now, over 160 years later, instruments like the Advanced Camera for Surveys (ACS) and Wide Field Camera 3 (WFC3) on the NASA/ European Space Agency (ESA) Hubble Space Telescope allow us to marvel at the cluster and its contents in greater detail. European Space Agency Credit: ESA/Hubble & NASA, Acknowledgement: Gilles Chapdelaine.

HEAVY RAINFALL FALLS ON AUSTRALIAN COASTS

Caption Credit: NASA. The rainfall accumulation analysis above was computed from data generated by the Integrated Multi-satellite Retrievals for GPM (IMERG) during the period from April 28 to May 3, 2015. During this period IMERG algorithms continuously merged and interpolated satellite passive microwave precipitation estimates and microwave-calibrated infrared (IR) satellite estimates over the entire globe. Rainfall from cyclone Quang fell over the west coast and a non-tropical system pounded the east coast of Australia simultaneously during the past weekend. Cyclone Quang formed in the South Indian Ocean northwest of Australia on April 28, 2015. Quang's peak intensity of 115kts (133 mph) occurred while it was well off western Australia's coast. The heaviest rainfall with cyclone Quang also occurred during this period when the tropical cyclone was far out in the Indian Ocean northwest of Australia's coast. Total rainfall there was measured at over 454 mm (17.9 inches). Heavy rainfall of over 448 mm (17.7 inches) was also found by this analysis in the Coral Sea off Australia's southeast coast. Rainfall totals of above 356 mm (14.0 inches) were analyzed with the passage of the low pressure center over southeastern Australia. Flooding in this area caused the reported deaths of at least four Australians. Credits-SSAI-NASA, Hal Pierce.

SOMEWHERE OVER THE GRAND CANYON

From the International Space Station, NASA astronaut Terry Virts took this photograph of an early morning sunrise over the Grand Canyon and posted it to social media on May 10, 2015. Because the station completes each trip around the globe in about 92 minutes, the crew experiences 16 sunrises and sunsets each day. The space station and its crew orbit Earth from an altitude of 220 miles, traveling at a speed of approximately 17,500 miles per hour. Because the station completes each trip around the globe in about 92 minutes, the crew experiences 16 sunrises and sunsets each day. Image Credit: NASA. Last Updated: May 13, 2015. Editor: Sarah Loff

THE ISS SOALR ARRAY

Caption Credit: NASA. Expedition 43 Flight Engineer Samantha Cristoforetti of the European Space Agency (ESA) photographed the giant solar arrays on the International Space Station on Feb. 12, 2015. The space station's solar arrays contain a total of 262,400 solar cells and cover an area of about 27,000 square feet (2,500 square meters) -- more than half the area of a football field. A solar array's wingspan of 240 feet (73 meters) is longer than a Boeing 777's wingspan, which is 212 feet (65 meters). Altogether, the four sets of arrays can generate 84 to 120 kilowatts of electricity -- enough to provide power to more than 40 homes. The solar arrays produce more power than the station needs at one time for station systems and experiments. When the station is in sunlight, about 60 percent of the electricity that the solar arrays generate is used to charge the station's batteries. At times, some or all of the solar arrays are in the shadow of Earth or the shadow of part of the station. This means that those arrays are not collecting sunlight. The batteries power the station when it is not in the sun. Image Credit: ESA/NASA

THE ATMOSPHERE ON MERCURY

Caption Credit: NASA. The Mercury Atmosphere and Surface Composition Spectrometer (MASCS) instrument aboard NASA's MESSENGER spacecraft was designed to study both the exosphere and surface of the planet Mercury. To learn more about the minerals and surface processes on Mercury, the Visual and Infrared Spectrometer (VIRS) portion of MASCS has been diligently collecting single tracks of spectral surface measurements since MESSENGER entered Mercury orbit on March 17, 2011. The track coverage is now extensive enough that the spectral properties of both broad terrains and small, distinct features such as pyroclastic vents and fresh craters can be studied. To accentuate the geological context of the spectral measurements, the MASCS data have been overlain on the monochrome mosiac from the Mercury Dual Imaging System (MDIS), an instrument with wide- and narrow-angle cameras to map the rugged landforms and spectral variations on Mercury’s surface. Click on the image to explore the colorful diversity of surface materials in more detail! The MESSENGER spacecraft is the first ever to orbit the planet Mercury, and the spacecraft's seven scientific instruments and radio science investigation are unraveling the history and evolution of the solar system's innermost planet. In the mission's more than four years of orbital operations, MESSENGER has acquired over 250,000 images and extensive other data sets. MESSENGER's highly successful orbital mission is about to come to an end, as the spacecraft runs out of propellant and the force of solar gravity causes it to impact the surface of Mercury near the end of April 2015. Image Credit: NASA/Johns Hopkins University Applied Physics Laboratory/Carnegie Institution of Washington

NASA'S GREASED LIGHTNING BATTERY PLANE

Caption Credit: NASA. A team at NASA's Langley Research Center is developing a concept of a battery-powered plane that has 10 engines and can take off like a helicopter and fly efficiently like an aircraft. The prototype, called Greased Lightning or GL-10, is currently in the design and testing phase. The initial thought was to develop a 20-foot wingspan (6.1 meters) aircraft powered by hybrid diesel/electric engines, but the team started with smaller versions for testing, built by rapid prototyping. During a recent spring day the engineers took the GL-10 to test its wings at a military base about two hours away from NASA Langley. The remotely piloted plane has a 10-foot wingspan (3.05 meters), eight electric motors on the wings, two electric motors on the tail and weighs a maximum of 62 pounds (28.1 kilograms) at take off. This photograph captures the GL-10 prototype taking off in hover mode like a helicopter. Image Credit: NASA Langley/David C. Bowman

3-D PRINTER AND MANUFACTURING IN SPACE

Caption Credit: NASA. The International Space Station’s 3-D printer has manufactured the first 3-D printed object in space, paving the way to future long-term space expeditions. The object, a printhead faceplate, is engraved with names of the organizations that collaborated on this space station technology demonstration: NASA and Made In Space, Inc., the space manufacturing company that worked with NASA to design, build and test the 3-D printer. This image of the printer, with the Microgravity Science Glovebox Engineering Unit in the background, was taken in April 2014 during flight certification and acceptance testing at NASA's Marshall Space Flight Center in Huntsville, Alabama, prior to its launch to the station aboard a SpaceX commercial resupply mission. The first objects built in space will be returned to Earth in 2015 for detailed analysis and comparison to the identical ground control samples made on the flight printer prior to launch. The goal of this analysis is to verify that the 3-D printing process works the same in microgravity as it does on Earth. The printer works by extruding heated plastic, which then builds layer upon layer to create three-dimensional objects. Testing this on the station is the first step toward creating a working "machine shop" in space. This capability may decrease cost and risk on the station, which will be critical when space explorers venture far from Earth and will create an on-demand supply chain for needed tools and parts. Long-term missions would benefit greatly from onboard manufacturing capabilities. Data and experience gathered in this demonstration will improve future 3-D manufacturing technology and equipment for the space program, allowing a greater degree of autonomy and flexibility for astronauts. Image Credit-NASA-Emmett Given.

AEGIS BALLISTIC MISSILE DEFENSE SYSTEM COMPLETES SIMULATED ENGAGEMENTS

Caption Credit: U.S. DOD. February 24, 2015 Aegis Ballistic Missile Defense System Completes Successful Tracking and Simulated Engagements of Three Short-Range Ballistic Missiles. This test was designated Flight Test Other (FTX)-19. This was the first flight test to assess the ability of the Aegis BMD 4.0 weapon system to simulate engagements of a raid consisting of three short-range, separating ballistic missile targets. This was also the first time Aegis BMD 4.0 ships used the DWES capability with live targets. The MDA will use test results to improve and enhance the Ballistic Missile Defense System and support the advancement of Phase 2 of the Phased Adaptive Approach for missile defense in Europe to provide protection of U.S. deployed forces and our European allies and partners.

FROSTY MARS

Caption: Livio Tornabene, Ryan Hopkins, Kayle Hansen and Eric Pilles. This image of an area on the surface of Mars, approximately 1.5 by 3 kilometers in size, shows frosted gullies on a south-facing slope within a crater. At this time of year, only south-facing slopes retain the frost, while the north-facing slopes have melted. Gullies are not the only active geologic process going on here. A small crater is visible at the bottom of the slope. The image was acquired on Nov. 30, 2014, by the High Resolution Imaging Science Experiment (HiRISE) camera, one of six instruments on NASA's Mars Reconnaissance Orbiter. The University of Arizona, Tucson, operates HiRISE, which was built by Ball Aerospace & Technologies Corp., Boulder, Colorado. NASA's Jet Propulsion Laboratory, a division of the California Institute of Technology in Pasadena, manages the Mars Reconnaissance Orbiter Project for NASA's Science Mission Directorate, Washington. Image Credit: NASA/JPL-Caltech/University of Arizona.

USS THEODORE ROSEVELT SUPPORTING OPERATIONS IN SYRIA AND IRAQ

U.S. NAVY DISPLAYS 28,000 POUNDS OF COCAINE

Caption Credit: U.S. DOD. 150416-N-UL721-037 SAN DIEGO (April 16, 2015) More than 28,000 pounds of cocaine, worth over $424 million, seized in 19 separate interdictions awaits its offload aboard the U.S. Coast Guard Cutter Boutwell (WHEC 719) at Naval Base San Diego. U.S. Navy, U.S. Coast Guard and Royal Canadian Navy ships have seized more cocaine in the last six months than in all of fiscal year 2014. Joint, interagency, and international relationships strengthen U.S. 3rd Fleet's ability to respond to crises and protect the collective maritime interests of the U.S. and its allies and partners. (U.S. Navy photo by Mass Communication Specialist 2nd Class Corey T. Jones/Released)

SPACEX FALCON 9 ROCKET CARRYING SUPPLIES FOR ISS

Caption Credit: NASA. A SpaceX Falcon 9 rocket lifts off from Space Launch Complex 40 at Cape Canaveral Air Force Station carrying the Dragon resupply spacecraft on the sixth commercial resupply services mission to the International Space Station. Liftoff was at 4:10 p.m. EDT, Tuesday, April 14. Research that will help prepare NASA astronauts and robotic explorers for future missions to Mars is among the two tons of cargo on its way to the International Space Station aboard Dragon. The mission is the company's sixth cargo delivery flight to the station through NASA’s Commercial Resupply Services contract. Dragon's cargo will support approximately 40 of the more than 250 science and research investigations that will be performed during Expeditions 43 and 44, including numerous human research investigations for NASA astronaut Scott Kelly's one-year mission in space. Image Credit: NASA/Kim Shiflett

SEA ICE OFF COAST OF EAST ANTARCTICA

On April 5, 2015, the Moderate Resolution Imaging Spectroradiometer (MODIS) on NASA’s Terra satellite acquired this natural-color image of sea ice off the coast of East Antarctica’s Princess Astrid Coast. White areas close to the continent are sea ice, while white areas in the northeast corner of the image are clouds. One way to better distinguish ice from clouds is with false-color imagery. In the false-color view of the scene here, ice is blue and clouds are white. The image was acquired after Antarctic sea ice had passed its annual minimum extent (reached on Feb. 20, 2015), and had resumed expansion toward its maximum extent (usually reached in September). More information: NASA's Earth Observatory Image Credit: NASA/Jeff Schmaltz, LANCE/EOSDIS Rapid Response. Caption: Kathryn Hansen.

WATER, WATER EVERYWHERE?

Caption Credit: NASA. As NASA missions explore our solar system and search for new worlds, they are finding water in surprising places. Water is but one piece of our search for habitable planets and life beyond Earth, yet it links many seemingly unrelated worlds in surprising ways. Perhaps the most surprising water worlds are the five icy moons of Jupiter and Saturn that show strong evidence of oceans beneath their surfaces: Ganymede, Europa and Callisto at Jupiter, and Enceladus and Titan at Saturn. Scientists using NASA's Hubble Space Telescope recently provided powerful evidence that Ganymede has a saltwater, sub-surface ocean, likely sandwiched between two layers of ice. In this artist’s concept, the moon Ganymede orbits the giant planet Jupiter. The Hubble Space Telescope observed aurorae on the moon generated by Ganymede’s magnetic fields. A saline ocean under the moon’s icy crust best explains shifting in the auroral belts measured by Hubble. More: The Solar System and Beyond is Awash in Water Image Credit: NASA/ESA.

HEIST TESTED AT ARMSTRONG FLIGHT RESEARCH CENTER

Caption Credit: NASA. Leading Edge Asynchronous Propeller Technology (LEAPTech) project researchers at NASA's Armstrong Flight Research Center are performing ground testing of a 31-foot-span, carbon composite wing section with 18 electric motors. The LEAPTech project will test the premise that tighter propulsion-airframe integration, made possible with electric power, will deliver improved efficiency and safety, as well as environmental and economic benefits. The experimental wing, called the Hybrid-Electric Integrated Systems Testbed (HEIST), is mounted on a specially modified truck. Testing on the mobile ground rig assembly will provide valuable data and risk reduction applicable to future flight research. Instead of being installed in a wind tunnel, the HEIST wing section will remain attached to load cells on a supporting truss while the vehicle is driven at speeds up to 70 miles per hour across a dry lakebed at Edwards Air Force Base. LEAPTech to Demonstrate Electric Propulsion Technologies Image Credit: Joby Aviation.

MINERAL VEINS ON MOUNT SHARP, MARS

Caption Credit: NASA. This view from the Mast Camera (Mastcam) on NASA's Curiosity Mars rover shows a network of two-tone mineral veins at an area called "Garden City" on lower Mount Sharp. The veins combine light and dark material. The veins at this site jut to heights of up to about 2.5 inches (6 centimeters) above the surrounding rock, and their widths range up to about 1.5 inches (4 centimeters). Figure 1 includes a 30-centimeter scale bar (about 12 inches). Mineral veins such as these form where fluids move through fractured rocks, depositing minerals in the fractures and affecting chemistry of the surrounding rock. In this case, the veins have been more resistant to erosion than the surrounding host rock. This scene is a mosaic combining 28 images taken with Mastcam's right-eye camera, which has a telephoto lens with a focal length of 100 millimeters. The component images were taken on March 18, 2015, during the 929th Martian day, or sol, of Curiosity's work on Mars. The color has been approximately white-balanced to resemble how the scene would appear under daytime lighting conditions on Earth. Malin Space Science Systems, San Diego, built and operates the rover's Mastcam. NASA's Jet Propulsion Laboratory, a division of the California Institute of Technology, Pasadena, manages the Mars Science Laboratory Project for NASA's Science Mission Directorate, Washington. JPL designed and built the project's Curiosity rover. Feature: Curiosity Eyes Prominent Mineral Veins on Mars. Image Credit-NASA-JPL-Caltech-MSSS.

A LOOK AT SUPER TYPHOON MAYSAK FROM ISS

Caption Credit: NASA. Typhoon Maysak strengthened into a super typhoon on March 31, reaching Category 5 hurricane status on the Saffir-Simpson Wind Scale. ESA Astronaut Samantha Cristoforetti captured this image while flying over the weather system on board the International Space Station. The Tropical Rainfall Measuring Mission (TRMM) and Global Precipitation Measurement (GPM) satellites, both co-managed by NASA and the Japan Aerospace Exploration Agency, captured rainfall and cloud data that revealed heavy rainfall and high thunderstorms in the strengthening storm. The TRMM satellite has been collecting valuable scientific data since November 1997. Early on March 30, the satellite collected rainfall data as it flew directly above Maysak at 04:14 UTC (12:14 a.m. EDT) when maximum sustained winds were near 85 knots (98 mph). Rainfall data was collected by TRMM's Microwave Imager (TMI) and Precipitation Radar (PR) instruments and showed heaviest rainfall southwest of the center, and in fragmented bands of thunderstorms northeast of the center. In both of those places rainfall was in excess of 50 mm/2 inches per hour. More information. Image Credit-ESA-NASA-Samantha Cristoforetti.

U.S. AIR FORCE THUNDERBIRDS PERFORM DEMONSTRATION AT NELLIS AFB

WAITING FOR TAKEOFF ABOARD USS BOHNOMME RICHARD

Caption Credit: U.S. Navy. EAST CHINA SEA (March 24, 2015) A Naval Aircrewman awaits takeoff on an MH-60S Sea Hawk helicopter assigned to Helicopter Sea Combat Squadron (HSC) 25 aboard the amphibious assault ship USS Bonhomme Richard (LHD 6). Bonhomme Richard is the lead ship of the Bonhomme Richard Amphibious Ready Group (ARG) and, along with the embarked 31st Marine Expeditionary Unit (31st MEU), is underway in the U.S. 7th Fleet area of responsibility. U.S. Navy photo by Mass Communication Specialist 3rd Class Kevin V. Cunningham (Released) 150324-N-UF697-009.

SOYUZ TMA-16M SPACECRAFT ROLLS OUT

The Soyuz TMA-16M spacecraft is seen after having rolled out by train to the launch pad at the Baikonur Cosmodrome, Kazakhstan, Wednesday, March 25, 2015. NASA astronaut Scott Kelly and Russian cosmonauts Mikhail Kornienko and Gennady Padalka of the Russian Federal Space Agency (Roscosmos) are scheduled to launch to the International Space Station in the Soyuz at 3:42 p.m. EDT, Friday, March 27 (March 28, Kazakh time). As the one-year crew, Kelly and Kornienko will return to Earth on the Soyuz TMA-18M in March 2016. Most expeditions to the space station last four to six months. By doubling the length of this mission, researchers hope to better understand how the human body reacts and adapts to long-duration spaceflight. This knowledge is critical as NASA looks toward human journeys deeper into the solar system, including to and from Mars, which could last 500 days or longer. More: A Year in Space Image Credit: NASA/Bill Ingalls.

OPPORTUNITY'S VIEW OF MARATHON VALLEY

This view from NASA's Mars Exploration Rover Opportunity shows part of "Marathon Valley," a destination on the western rim of Endeavour Crater, as seen from an overlook north of the valley. The scene spans from east, at left, to southeast. It combines four pointings of the rover's panoramic camera (Pancam) on March 13, 2015, during the 3,958th Martian day, or sol, of Opportunity's work on Mars. The rover team selected Marathon Valley as a science destination because observations of this location using the Compact Reconnaissance Imaging Spectrometer for Mars (CRISM) instrument on NASA's Mars Reconnaissance Orbiter yielded evidence of clay minerals, a clue to ancient wet environments. By the time Opportunity explores Marathon Valley, the rover will have exceeded a total driving distance equivalent to an Olympic marathon. Opportunity has been exploring the Meridiani Planum region of Mars since January 2004. This version of the image is presented in approximate true color by combining exposures taken through three of the Pancam's color filters at each of the four camera pointings, using filters centered on wavelengths of 753 nanometers (near-infrared), 535 nanometers (green) and 432 nanometers (violet). Image Credit: NASA/JPL-Caltech/Cornell Univ./Arizona State Univ.

MAGNETOSPHERIC MULTISCALE SPACECRAFT LAUNCH

Caption Credit: NASA. The United Launch Alliance Atlas V rocket with NASA’s Magnetospheric Multiscale (MMS) spacecraft onboard launches from the Cape Canaveral Air Force Station Space Launch Complex 41, Thursday, March 12, 2015, Florida. NASA’s MMS mission studies the mystery of how magnetic fields around Earth connect and disconnect, explosively releasing energy via a process known as magnetic reconnection. MMS consists of four identical spacecraft that work together to provide the first three-dimensional view of this fundamental process, which occurs throughout the universe. Photo Credit: NASA/Aubrey Gemignani.

RETURN OF SOYUZ TMA-14M SPACECRAFT

The Soyuz TMA-14M spacecraft is seen as it lands with International Space Station Expedition 42 commander Barry Wilmore of NASA, Alexander Samokutyaev of the Russian Federal Space Agency (Roscosmos) and Elena Serova of Roscosmos near the town of Zhezkazgan, Kazakhstan. The landing took place on the evening of Wednesday, March 11 in the U.S, and early in the morning on Thursday, March 12, in Kazakhstan. The three crew members returned to Earth after a 167-day mission on the orbital outpost that included hundreds of scientific experiments and several spacewalks to prepare the orbiting laboratory for future arrivals by U.S. commercial crew spacecraft. Credit: NASA/Bill Ingalls.

GIVING ORION A LIFT

Caption Credit: NASA. Engineers across the country have been busy taking a closer look at NASA's Orion spacecraft and the data it produced during its successful flight test in December 2014. Inside the Launch Abort System Facility at NASA's Kennedy Space Center in Florida, Orion was lifted using a special crane for removal of its heat shield on Feb. 13, 2015. In the background, technicians move the heat shield on a work stand. The spacecraft’s heat shield protected Orion as it reentered Earth’s atmosphere at searing temperatures. Removing the back shell allows the team to get a closer look at Orion’s systems to see how they fared during the trip to space. The heat shield was removed in preparation for shipment to NASA’s Marshall Space Flight Center in Huntsville, Alabama, where special equipment will be used to remove its ablative material. From there, the heat shield will be shipped to NASA’s Langley Research Center in Hampton, Virginia, where it will be outfitted on a test article for water impact testing. Meanwhile, NASA and Lockheed Martin, the prime contractor for Orion, continue to take a look at the data the flight test produced to validate pre-flight models and improve the spacecraft’s design. Analysis of data obtained during its two-orbit, four-and-a-half hour mission Dec. 5 will provide engineers detailed information on how the spacecraft fared. Photo Credit-NASA-Jim Grossmann.

DAWN ARIVES TO DWARF PLANET CERES

Caption Credit: NASA. NASA's Dawn spacecraft has become the first mission to achieve orbit around a dwarf planet. The spacecraft was approximately 38,000 miles (61,000) kilometers from Ceres when it was captured by the dwarf planet’s gravity at about 4:39 a.m. PST (7:39 a.m. EST) Friday, March 6. This image of Ceres was taken by the Dawn spacecraft on March 1, just a few days before the mission achieved orbit around the previously unexplored world. The image shows Ceres as a crescent, mostly in shadow because the spacecraft's trajectory put it on a side of Ceres that faces away from the sun until mid-April. When Dawn emerges from Ceres' dark side, it will deliver ever-sharper images as it spirals to lower orbits around the planet. The image was obtained at a distance of about 30,000 miles (about 48,000 kilometers) at a sun-Ceres-spacecraft angle, or phase angle, of 123 degrees. Image scale on Ceres is 1.9 miles (2.9 kilometers) per pixel. Ceres has an average diameter of about 590 miles (950 kilometers). Dawn's mission is managed by NASA's Jet Propulsion Laboratory, Pasadena, California, for NASA's Science Mission Directorate in Washington. Dawn is a project of the directorate's Discovery Program, managed by NASA's Marshall Space Flight Center in Huntsville, Alabama. The University of California, Los Angeles, is responsible for overall Dawn mission science. Orbital ATK Inc., in Dulles, Virginia, designed and built the spacecraft. The German Aerospace Center, the Max Planck Institute for Solar System Research, the Italian Space Agency and the Italian National Astrophysical Institute are international partners on the mission team. Image Credit: NASA/JPL-Caltech/UCLA/MPS/DLR/IDA

COMET C/2014 Q2 KNOWN AS LOVEJOY

Comet C/2014 Q2 (Lovejoy) is one of more than 32 comets imaged by NASA's NEOWISE mission from December 2013 to December 2014. This image of comet Lovejoy combines a series of observations made in November 2013, when comet Lovejoy was 1.7 astronomical units from the sun. (An astronomical unit is the distance between Earth and the sun.) The image spans half of one degree. It shows the comet moving in a mostly west and slightly south direction. (North is 26 degrees to the right of up in the image, and west is 26 degrees downward from directly right.) The red color is caused by the strong signal in the NEOWISE 4.6-micron wavelength detector, owing to a combination of gas and dust in the comet's coma. Comet Lovejoy is the brightest comet in Earth's sky in early 2015. Image credit: NASA/JPL-Caltech.

USS CARL VINSON SUPPORTS STRIKES IN IRAQ, SYRIA

ISS VIEW OF THE ISLAND OF HAWAII

Caption Credit: NASA. From the International Space Station, European Space Agency astronaut Samantha Cristoforetti (@AstroSamantha) took this photograph of the island of Hawaii and posted it to social media on Feb. 28, 2015. Cristoforetti wrote, "And suddenly as we flew over the Pacific... the island of #Hawaii with its volcanoes! #HelloEarth".Crewmembers on the space station photograph the Earth from their unique point of view located 200 miles above the surface as part of the Crew Earth Observations program. Photographs record how the planet is changing over time, from human-caused changes like urban growth and reservoir construction, to natural dynamic events such as hurricanes, floods and volcanic eruptions. Astronauts have used hand-held cameras to photograph the Earth for more than 40 years, beginning with the Mercury missions in the early 1960s. The ISS maintains an altitude between 220 - 286 miles (354 - 460 km) above the Earth, and an orbital inclination of 51.6˚, providing an excellent stage for observing most populated areas of the world. Image Credit: NASA/ESA/Samantha Cristoforetti.

GETTING READY FOR VISITORS IN SPACE

Caption Credit: NASA. NASA astronaut Barry Wilmore works outside the International Space Station on the first of three spacewalks preparing the station for future arrivals by U.S. commercial crew spacecraft, Saturday, Feb. 21, 2015. Fellow spacewalker Terry Virts, seen reflected in the visor, shared this photograph on social media. The spacewalks are designed to lay cables along the forward end of the U.S. segment to bring power and communication to two International Docking Adapters slated to arrive later this year. The new docking ports will welcome U.S. commercial spacecraft launching from Florida beginning in 2017, permitting the standard station crew size to grow from six to seven and potentially double the amount of crew time devoted to research. The second and third spacewalks are planned for Wednesday, Feb. 25 and Sunday, March 1, with Wilmore and Virts participating in all three. Image Credit: NASA.

"LIVE LONG AND PROSPER"

SMAP LAUNCHES INTO SPACE

Caption Credit: NASA. A United Launch Alliance Delta II rocket with the Soil Moisture Active Passive (SMAP) observatory onboard is seen in this long exposure photograph as it launches from Space Launch Complex 2, Saturday, Jan. 31, 2015, Vandenberg Air Force Base, Calif. SMAP is NASA’s first Earth-observing satellite designed to collect global observations of surface soil moisture and its freeze/thaw state. SMAP will provide high resolution global measurements of soil moisture from space. The data will be used to enhance scientists' understanding of the processes that link Earth's water, energy, and carbon cycles. )Photo Credit-NASA-Bill Ingalls.

2015: THE YEAR OF LIGHT

The year of 2015 has been declared the International Year of Light (IYL) by the United Nations. Organizations, institutions, and individuals involved in the science and applications of light will be joining together for this yearlong celebration to help spread the word about the wonders of light. NASA’s Chandra X-ray Observatory explores the universe in X-rays, a high-energy form of light. By studying X-ray data and comparing them with observations in other types of light, scientists can develop a better understanding of objects likes stars and galaxies that generate temperatures of millions of degrees and produce X-rays. To recognize the start of IYL, the Chandra X-ray Center is releasing a set of images that combine data from telescopes tuned to different wavelengths of light. From a distant galaxy to the relatively nearby debris field of an exploded star, these images demonstrate the myriad ways that information about the universe is communicated to us through light. In this image, an expanding shell of debris called SNR 0519-69.0 is left behind after a massive star exploded in the Large Magellanic Cloud, a satellite galaxy to the Milky Way. Multimillion degree gas is seen in X-rays from Chandra, in blue. The outer edge of the explosion (red) and stars in the field of view are seen in visible light from the Hubble Space Telescope. Chandra Celebrates the International Year of Light. Image Credit: NASA-CXC-SAO.

NASA SENDS SOUNDING ROCKETS INTO AUROAS

The interaction of solar winds and Earth’s atmosphere produces northern lights, or auroras, that dance across the night sky and mesmerize the casual observer. However, to scientists this interaction is more than a light display. It produces many questions about the role it plays in Earth’s meteorological processes and the impact on the planet’s atmosphere. To help answer some of these questions, NASA suborbital sounding rockets carrying university-developed experiments -- the Mesosphere-Lower Thermosphere Turbulence Experiment (M-TeX) and Mesospheric Inversion-layer Stratified Turbulence (MIST) -- were launched into auroras from the Poker Flat Research Range in Alaska. The experiments explore the Earth’s atmosphere’s response to auroral, radiation belt and solar energetic particles and associated effects on nitric oxide and ozone. This composite shot of all four sounding rockets for the M-TeX and MIST experiments is made up of 30 second exposures. The rocket salvo began at 4:13 a.m. EST, Jan. 26, 2015. A fifth rocket carrying the Auroral Spatial Structures Probe remains ready on the launch pad. The launch window for this experiment runs through Jan. 27. Image Credit: NASA-Jamie Adkin.

THE FIRST BIG SOLAR FLARE OF 2015

AIR FORCE BUILDS AN ICE BRIDGE IN ALASKA

K2: PROFILE OF A PLANET HUNTER

Caption Credit: NASA. The artistic impression shows NASA's planet-hunting Kepler spacecraft operating in a new mission profile called K2. In May the spacecraft began its new mission observing in the ecliptic plane, the orbital path of Earth around the sun, depicted by the grey-blue line marked by opaque cross-like shapes. Each shape represents the field-of-view of an observing campaign. The K2 mission observes a specific portion of the distant sky for approximately 80 days, until it is necessary to rotate the spacecraft to prevent sunlight from entering the telescope. The spacecraft orbits the sun every 372 days as it trails Earth, allowing for four full campaigns per orbit or year. The arching band of stars is the plane of the Milky Way Galaxy. Using publicly available data collected by the spacecraft in February 2014 during the performance concept test to prove K2 would work, astronomers have confirmed the first exoplanet detected by the K2 mission. The newly confirmed planet, HIP 116454b, is 2.5 times the diameter of Earth, and closely orbits a star smaller and cooler than our sun once every nine days, making the planet too hot for life as we know it. The star and planet are 180 light-years from Earth toward the constellation Pisces. In May 2013, data collection for Kepler's extended prime mission came to an end when the second of four reaction wheels used to stabilize the spacecraft failed. Without at least three functioning reaction wheels, Kepler couldn’t be pointed at the original field with sufficient stability to precisely measure the dimming of starlight caused by a planet when it passes or transits in front of a distant star. Rather than giving up on the stalwart spacecraft, a team of scientists and engineers crafted a resourceful strategy to use pressure from sunlight as a virtual reaction wheel to help control the spacecraft while observing the sky in the ecliptic plane. The resulting K2 mission promises to not only continue Kepler’s planet hunt, but to expand that search to bright nearby stars which harbor planets that allow scientists to study them in detail to better understand their composition. K2 will also introduce new opportunities to observe star clusters, active galaxies, and supernovae. Link to full NASA press release: NASA’s Kepler Reborn, Makes First Exoplanet Find of New Mission Credit: NASA Ames-JPL-Caltech-T Pyle.

MARS ROVER VISITS THE LAKE

Caption Credit: NASA. This evenly layered rock photographed by the Mast Camera (Mastcam) on NASA's Curiosity Mars Rover shows a pattern typical of a lake-floor sedimentary deposit not far from where flowing water entered a lake. The scene combines multiple frames taken with Mastcam's right-eye camera on Aug. 7, 2014, during the 712th Martian day, or sol, of Curiosity's work on Mars. It shows an outcrop at the edge of "Hidden Valley," seen from the valley floor. This view spans about 5 feet (1.5 meters) across in the foreground. The color has been approximately white-balanced to resemble how the scene would appear under daytime lighting conditions on Earth. Figure A is a version with a superimposed scale bar of 50 centimeters (about 20 inches). This is an example of a thick-laminated, evenly-stratified rock type that forms stratigraphically beneath cross-bedded sandstones regarded as ancient river deposits. These rocks are interpreted to record sedimentation in a lake, as part of or in front of a delta, where plumes of river sediment settled out of the water column and onto the lake floor. NASA's Jet Propulsion Laboratory, a division of the California Institute of Technology, Pasadena, manages the Mars Science Laboratory Project for NASA's Science Mission Directorate, Washington. JPL designed and built the project's Curiosity rover. Malin Space Science Systems, San Diego, built and operates the rover's Mastcam. Related: NASA’s Curiosity Rover Finds Clues to How Water Helped Shape Martian Landscape Image Credit: NASA/JPL-Caltech/MSSS

THE END OF THE MISSION IN AFGHAISTAN

Caption Credit: U.S. DOD. A U.S. Army CH-47 Chinook helicopter lands while coalition troops prepare for the International Security Assistance Force Joint Command and U.S. Army XVIII Airborne Corps end-of-mission ceremony on North Kabul International Airport in Afghanistan, Dec. 8, 2014. The command's five-year mission was to neutralize the insurgency in specified areas and support improved governance and development, in order to protect the Afghan people and provide a secure environment for sustainable peace. U.S. Air Force photo by Staff Sgt. Perry Aston

NASA DEVELOPING TECH TO IMPROVE FUEL EFFICIENCY, NOISE POLUTION

Caption Credit: NASA. NASA's green aviation project is one step closer to developing technology that could make future airliners quieter and more fuel-efficient with the successful flight test of a wing surface that can change shape in flight. This past summer, researchers replaced an airplane’s conventional aluminum flaps with advanced, shape-changing assemblies that form seamless bendable and twistable surfaces. Flight testing will determine whether flexible trailing-edge wing flaps are a viable approach to improve aerodynamic efficiency and reduce noise generated during takeoffs and landings. For the initial Adaptive Compliant Trailing Edge (ACTE) flight, shown in this image, the experimental control surfaces were locked at a specified setting. Varied flap settings on subsequent tests will demonstrate the capability of the flexible surfaces under actual flight conditions. ACTE technology is expected to have far-reaching effects on future aviation. Advanced lightweight materials will reduce wing structural weight and give engineers the ability to aerodynamically tailor the wings to promote improved fuel economy and more efficient operations, while reducing environmental impacts. NASA Tests Revolutionary Shape Changing Aircraft Flap for the First Time Image Credit: NASA/Ken Ulbrich.

ORION PASSES SPACEPORT VEHICLE ASSEMBLY BUILDING

Caption Credit: NASA. At NASA's Kennedy Space Center in Florida, the agency's Orion spacecraft passes the spaceport's iconic Vehicle Assembly Building as it is transported to Launch Complex 37 at Cape Canaveral Air Force Station on the evening of Tuesday, Nov. 11, 2014. After arrival at the launch pad, United Launch Alliance engineers and technicians will lift Orion and mount it atop its Delta IV Heavy rocket. Orion began its journey to the launch pad at at the Launch Abort System Facility, where a 52-foot-tall protective fairing and the launch abort system were attached to the 10-foot, 11-inch-tall crew module. Resting atop a specialized Kamag transporter, Orion was moved to Space Launch Complex 37B at Cape Canaveral Air Force Station. The move began at 8:54 p.m. EST and concluded at 3:07 a.m., Wednesday, Nov. 12. Orion is the exploration spacecraft designed to carry astronauts to destinations not yet explored by humans, including an asteroid and Mars. It will have emergency abort capability, sustain the crew during space travel and provide safe re-entry from deep space return velocities. Orion is scheduled to launch Dec. 4, 2014 atop a United Launch Alliance Delta IV Heavy rocket in its first unpiloted flight test, and in 2018 on NASA’s Space Launch System rocket. Image Credit: NASA/Kim Shiflett.

NuSTAR FINDS ENERGETIC PULSAR

Image and caption credit: NASA/JPL-Caltech/SAO. The blue dot in this image marks the spot of an energetic pulsar -- the magnetic, spinning core of star that blew up in a supernova explosion. NASA's Nuclear Spectroscopic Telescope Array, or NuSTAR, discovered the pulsar by identifying its telltale pulse -- a rotating beam of X-rays, that like a cosmic lighthouse, intersects Earth every 0.2 seconds. The pulsar, called PSR J1640-4631, lies in our inner Milky Way galaxy about 42,000 light-years away. It was originally identified by as an intense source of gamma rays by the High Energy Stereoscopic System (H.E.S.S.) in Namibia. NuSTAR helped pin down the source of the gamma rays to a pulsar. The other pink dots in this picture show low-energy X-rays detected by NASA's Chandra X-ray Observatory. In this image, NuSTAR data is blue and shows high-energy X-rays with 3 to 79 kiloelectron volts; Chandra data is pink and shows X-rays with 0.5 to 10 kiloeletron volts. The background image shows infrared light and was captured by NASA's Spitzer Space Telescope.

ULTRA VIOLET EXTREME

NASA Caption: The sun emitted a significant solar flare on Oct. 19, 2014, peaking at 1:01 a.m. EDT. NASA's Solar Dynamics Observatory, which is always observing the sun, captured this image of the event in extreme ultraviolet wavelength of 131 Angstroms – a wavelength that can see the intense heat of a flare and that is typically colorized in teal. This flare is classified as an X1.1-class flare. X-class denotes the most intense flares, while the number provides more information about its strength. An X2 flare is twice as intense as an X1, and an X3 is three times as intense. Solar flares are powerful bursts of radiation. Harmful radiation from a flare cannot pass through Earth's atmosphere to physically affect humans on the ground, however -- when intense enough -- they can disturb the atmosphere in the layer where GPS and communications signals travel. > More: NASA's SDO Observes an X-class Solar Flare. Image Credit-NASA-Solar Dynamics Observatory.

GLACIERS AND MOUNTAINS OF WEST ANTARTICA

Caption Credit: NASA. Glaciers and mountains in the evening sun are seen on an Operation IceBridge research flight, returning from West Antarctica on Oct. 29, 2014. NASA is carrying out its sixth consecutive year of Operation IceBridge research flights over Antarctica to study changes in the continent’s ice sheet, glaciers and sea ice. This year’s airborne campaign revisits a section of the Antarctic ice sheet that recently was found to be in irreversible decline. IceBridge uses a suite of instruments that includes a laser altimeter, radar instruments, cameras, and a gravimeter, which is an instrument that detects small changes in gravity. These small changes reveal how much mass these glaciers have lost. Researchers plan to measure previously unsurveyed regions of Antarctica, such as the upper portions of Smith Glacier in West Antarctica, which is thinning faster than any other glaciers in the region. The mission also plans to collect data in portions of the Antarctic Peninsula, such as the Larsen C, George VI and Wilkins ice shelves and the glaciers that drain into them. The Antarctic Peninsula has been warming faster than the rest of the continent. In addition to extending the data record of NASA’s Ice, Cloud and Land Elevation Satellite (ICESat), which stopped collecting data in 2009, IceBridge will also help set the stage for ICESat-2 by measuring ice the satellite will fly over. > Operation IceBridge Antarctic 2014 Campaign Image Credit: NASA/Michael Studinger.

ANTARES ROCKET EXPLODES DURING LAUNCH

Attention: Antares rocket explodes on liftoff Monday, Oct. 27. NASA Caption: Orbital Antares Rocket at the Launch Pad: The Orbital Sciences Corporation Antares rocket, with the Cygnus spacecraft onboard, is seen on launch Pad-0A, Sunday, Oct. 26, 2014, at NASA's Wallops Flight Facility in Virginia. The Antares will launch with the Cygnus spacecraft filled with over 5,000 pounds of supplies for the International Space Station, including science experiments, experiment hardware, spare parts, and crew provisions. The Orbital-3 mission is Orbital Sciences' third contracted cargo delivery flight to the space station for NASA. Launch is scheduled for Monday, Oct. 27 at 6:45 p.m. EDT. Image Credit-NASA-Joel Kowsky.

THE ULTIMATE IN SUNBLOCK

A partial solar eclipse was visible from much of North America before sundown on Thursday, Oct.23. A partial eclipse occurs when the moon blocks a portion of the Sun from view. The Hinode spacecraft captured images of yesterday’s eclipse as it passed over North America using its X-ray Telescope. During the eclipse, the new moon eased across the Sun from right to left with the Sun shining brilliantly in the background. And as a stroke of good luck, this solar cycle’s largest active region, which has been the source of several large flares over the past week, was centered on the Sun’s disk as the moon transitted! Hinode is in the eighth year of its mission to observe the Sun. Previously, Hinode has observed numerous eclipses due to its high-altitude, sun-synchronous orbit. As viewed from Hinode’s vantage point in space, this eclipse was annular instead of partial, which means that the entire moon moved in front of the Sun but did not cover it completely. In this situation, a ring of the Sun encircles the dark disk of the moon. Led by the Japan Aerospace Exploration Agency (JAXA), the Hinode mission is a collaboration between the space agencies of Japan, the United States, the United Kingdom and Europe. NASA helped in the development, funding and assembly of the spacecraft's three science instruments. Hinode is part of the Solar Terrestrial Probes (STP) Program within the Heliophysics Division of NASA's Science Mission Directorate in Washington. NASA's Marshall Space Flight Center in Huntsville, Ala., manages the Hinode science operations. The Lockheed Martin Corp. in Palo Alto, Calif., is the lead U.S. investigator for the Solar Optical Telescope. Image Credit: NASA

SUPERNOVA EXPLOSION IN X-RAY LIGHT

Caption Credit: NASA. The destructive results of a powerful supernova explosion reveal themselves in a delicate tapestry of X-ray light, as seen in this image from NASA’s Chandra X-Ray Observatory and the European Space Agency's XMM-Newton. The image shows the remains of a supernova that would have been witnessed on Earth about 3,700 years ago. The remnant is called Puppis A, and is around 7,000 light years away and about 10 light years across. This image provides the most complete and detailed X-ray view of Puppis A ever obtained, made by combining a mosaic of different Chandra and XMM-Newton observations. Low-energy X-rays are shown in red, medium-energy X-rays are in green and high energy X-rays are colored blue. These observations act as a probe of the gas surrounding Puppis A, known as the interstellar medium. The complex appearance of the remnant shows that Puppis A is expanding into an interstellar medium that probably has a knotty structure. Supernova explosions forge the heavy elements that can provide the raw material from which future generations of stars and planets will form. Studying how supernova remnants expand into the galaxy and interact with other material provides critical clues into our own origins. A paper describing these results was published in the July 2013 issue of Astronomy and Astrophysics and is available online. The first author is Gloria Dubner from the Instituto de Astronomía y Física del Espacio in Buenos Aires in Argentina. Image credit: NASA/CXC/IAFE/G.Dubner et al & ESA/XMM-Newton.

ORBITING CARBON OBSERVATORY-2 IS ABOARD DELTA II ROCKET

Orbiting Carbon Observatory-2 (OCO-2) Aboard Delta II Rocket. The launch gantry is rolled back to reveal the United Launch Alliance Delta II rocket with the Orbiting Carbon Observatory-2 (OCO-2) satellite onboard, at the Space Launch Complex 2, Monday, June 30, 2014, Vandenberg Air Force Base, Calif. OCO-2 will measure the global distribution of carbon dioxide, the leading human-produced greenhouse gas driving changes in Earth’s climate. Launch of OCO-2 is now scheduled for Wednesday, July 2 at 5:56 a.m. EDT (2:56 a.m. Pacific) at the opening of a 30-second window. Image Credit-NASA-Bill Ingalls. Caption Credit-NASA.

TEST VERSION OF ORION SPACECRAFT FLOATS

Caption Credit: NASA. A test version of NASA's Orion spacecraft floats inside the well deck of the U.S.S. Anchorage on Aug. 2, 2014, during recovery tests off the coast of California. A combined NASA and U.S. Navy team practiced recovery techniques over the weekend, in preparation for Orion's first trip to (and return from) space in Exploration Flight Test-1 (EFT-1) in December. Orion is the exploration spacecraft designed to carry astronauts to destinations not yet explored by humans, including an asteroid and Mars. It will have emergency abort capability, sustain the crew during space travel and provide safe re-entry from deep space return velocities. After traveling 3,600 miles into space on the uncrewed EFT-1, Orion will return to Earth at a speed of 20,000 miles per hour and endure temperatures near 4,000 degrees Fahrenheit before landing in the Pacific Ocean. > NASA Prepares for Second Orion Underway Recovery Test Image Credit: U.S. Navy photo by Mass Communication Specialist 1st Class Gary Keen

PROTOTYPE ROBOT WITH SMARTPHONE TO TEST3-D MAPPING, NAVIGATION

Image and Story Credit: NASA/Ames. Orbital Sciences Corporation's Cygnus spacecraft will carry 3,293 pounds (1,493.8 kg) of cargo on its upcoming commercial resupply mission to the International Space Station, including crew supplies, nanosatellites, student research and this prototype free-flying space robot equipped with a smartphone, known as Smart SPHERES (Synchronized Position Hold, Engage, Reorient Experimental Satellites). NASA has been testing SPHERES on the space station since 2011. This summer, astronauts will upgrade these existing space robots to use Google’s "Project Tango" smartphone, which features a custom 3-D sensor and multiple cameras. NASA will then use the Smart SPHERES to test free-flying 3-D mapping and navigation inside the space station. NASA is developing the Smart SPHERES to perform work on the space station that requires mobile sensing, such as environmental surveys to monitor levels of radiation, lighting and air quality. They also will be used to monitor inventory and conduct experiments. The development and testing of Smart SPHERES is funded by the Space Technology Mission Directorate at NASA Headquarters in Washington.

NASA'S NEW POWERFUL ROCKET

NASA’s Space Launch System, or SLS, will be the most powerful rocket in history. The flexible, evolvable design of this advanced, heavy-lift launch vehicle will meet a variety of crew and cargo mission needs. In addition to carrying the Orion spacecraft, SLS will transfer important cargo, equipment and science experiments to deep space, providing the nation with a safe, affordable and sustainable means to expand our reach in the solar system. It will allow astronauts aboard Orion to explore multiple deep-space destinations including an asteroid and ultimately Mars. The first configuration of the SLS launch vehicle will have a 70-metric-ton (77-ton) lift capacity and carry an uncrewed Orion spacecraft beyond low-Earth orbit to test the performance of the integrated system. As the SLS is evolved, it will be the most powerful rocket ever built and provide an unprecedented lift capability of 130 metric tons (143 tons) to enable missions even farther into our solar system. Image Credit: NASA.

THE GRANDEST CANYON IN THE SOLAR SYSTEM

Valles Marineris: The Grand Canyon of Mars: Explanation: The largest canyon in the Solar System cuts a wide swath across the face of Mars. Named Valles Marineris, the grand valley extends over 3,000 kilometers long, spans as much as 600 kilometers across, and delves as much as 8 kilometers deep. By comparison, the Earth's Grand Canyon in Arizona, USA is 800 kilometers long, 30 kilometers across, and 1.8 kilometers deep. The origin of the Valles Marineris remains unknown, although a leading hypothesis holds that it started as a crack billions of years ago as the planet cooled. Several geologic processes have been identified in the canyon. The above mosaic was created from over 100 images of Mars taken by Viking Orbiters in the 1970s. Image and story credit: Viking Project, USGS, NASA.

A LOOK AT THE DUNES OF MARS

Nili Patera is one of the most active dune fields on Mars. As such, it is continuously monitored with the HiRISE (High Resolution Imaging Science Experiment) camera, a science instrument aboard NASA's Mars Reconnaissance Orbiter, with a new image acquired about every six weeks. By monitoring the sand dune changes, we can determine how winds vary seasonally and year-to-year. This observation is one of the more recent Nili images, acquired on March 1, 2014. Compared to an image acquired on Nov. 22, 2012, changes are obvious. The ripples on the dunes have moved, as well some of the dune boundaries, such as the one at upper left. New landslides on the central dune's lee face are apparent. Such changes, in just 16 months (and finer scale changes have been seen in just a couple of weeks), demonstrate the effectiveness of wind in modifying the Martian landscape. HiRISE is one of six instruments on NASA's Mars Reconnaissance Orbiter. The University of Arizona, Tucson, operates the orbiter's HiRISE camera, which was built by Ball Aerospace & Technologies Corp., Boulder, Colo. NASA's Jet Propulsion Laboratory, a division of the California Institute of Technology in Pasadena, manages the Mars Reconnaissance Orbiter Project for the NASA Science Mission Directorate, Washington. > More information and image products Image Credit-NASA-JPL-Caltech-Univ. of Arizona Caption: Nathan Bridges.

ROBONAUT 2 GETS HIS SPACE LEGS

NASA has built and is sending a set of high-tech legs up to the International Space Station for Robonaut 2 (R2), the station's robotic crewmember. The new legs are scheduled to launch on the SpaceX-3 commercial cargo flight to the International Space Station, scheduled launch Monday, April 14 at 4:58 p.m. EDT from Cape Canaveral Air Force Station in Florida. These new legs, funded by NASA's Human Exploration and Operations and Space Technology mission directorates, will provide R2 the mobility it needs to help with regular and repetitive tasks inside and outside the space station. The goal is to free up the crew for more critical work, including scientific research. Once the legs are attached to the R2 torso, the robot will have a fully extended leg span of nine feet, giving it great flexibility for movement around the space station. Each leg has seven joints and a device on what would be the foot, called an "end effector," which allows the robot to take advantage of handrails and sockets inside and outside the station. A vision system for the end effectors also will be used to verify and eventually automate each limb's approach and grasp. Image Credit: NASA.

THE BLUE ANGELS 2014 AIR SHOW SEASON BEGINS MARCH 15

BIG FLARE BUT NO REAL SCARE

On Feb. 24, 2014, the sun emitted a significant solar flare, peaking at 7:49 p.m. EST. NASA's Solar Dynamics Observatory (SDO), which keeps a constant watch on the sun, captured images of the event. These SDO images from 7:25 p.m. EST on Feb. 24 show the first moments of this X-class flare in different wavelengths of light -- seen as the bright spot that appears on the left limb of the sun. Hot solar material can be seen hovering above the active region in the sun's atmosphere, the corona. Solar flares are powerful bursts of radiation, appearing as giant flashes of light in the SDO images. Harmful radiation from a flare cannot pass through Earth's atmosphere to physically affect humans on the ground, however -- when intense enough -- they can disturb the atmosphere in the layer where GPS and communications signals travel. Image Credit: NASA/SDO.

GALAXY SHOCK

FROM NASA: Roguish runaway stars can have a big impact on their surroundings as they plunge through the Milky Way galaxy. Their high-speed encounters shock the galaxy, creating arcs, as seen in this newly released image from NASA’s Spitzer Space Telescope. In this case, the speedster star is known as Kappa Cassiopeiae, or HD 2905 to astronomers. It is a massive, hot supergiant moving at around 2.5 million mph relative to its neighbors (1,100 kilometers per second). But what really makes the star stand out in this image is the surrounding, streaky red glow of material in its path. Such structures are called bow shocks, and they can often be seen in front of the fastest, most massive stars in the galaxy. Bow shocks form where the magnetic fields and wind of particles flowing off a star collide with the diffuse, and usually invisible, gas and dust that fill the space between stars. How these shocks light up tells astronomers about the conditions around the star and in space. Slow-moving stars like our sun have bow shocks that are nearly invisible at all wavelengths of light, but fast stars like Kappa Cassiopeiae create shocks that can be seen by Spitzer’s infrared detectors. Image Credit-NASA-JPL-Caltech

THE FIRST FLAG ON THE MOON

Photo taken by Neil Arstrong of Buzz Aldrin with U.S. flag on the Moon. (mission time: 110:10:33) Buzz salutes the U.S. Flag. His fingertips are visible on the far side of his faceplate. Note the well-defined footprints in the foreground. Buzz is facing up-Sun. There is a reflection of the Sun in his visor. At the bottom of Buzz's faceplate, note the white 'rim' which is slightly separated from his neckring. This 'rim' is the bottom of his gold visor, which he has pulled down. We can see the LEC straps hanging down inside of the ladder strut. In the foreground, we can see the foot-grabbing loops in the TV cable. The double crater under Neil's Lm window is beyond Buzz and the LM shadow

JAPANESE H-IIA ROCKET LAUNCHES FROM TANEGASHIMA SPACE CENTER

A LOOK AT THE CRAB NEBULA

This image shows a composite view of the Crab nebula, an iconic supernova remnant in our Milky Way galaxy, as viewed by the Herschel Space Observatory and the Hubble Space Telescope. Herschel is a European Space Agency (ESA) mission with important NASA contributions, and Hubble is a NASA mission with important ESA contributions. A wispy and filamentary cloud of gas and dust, the Crab nebula is the remnant of a supernova explosion that was observed by Chinese astronomers in the year 1054. The image combines Hubble's view of the nebula at visible wavelengths, obtained using three different filters sensitive to the emission from oxygen and sulphur ions and is shown here in blue. Herschel's far-infrared image reveals the emission from dust in the nebula and is shown here in red. While studying the dust content of the Crab nebula with Herschel, a team of astronomers have detected emission lines from argon hydride, a molecular ion containing the noble gas argon. This is the first detection of a noble-gas based compound in space. The Herschel image is based on data taken with the Photoconductor Array Camera and Spectrometer (PACS) instrument at a wavelength of 70 microns; the Hubble image is based on archival data from the Wide Field and Planetary Camera 2 (WFPC2). Image credit: ESA/Herschel/PACS/MESS Key Programme Supernova Remnant Team; NASA, ESA and Allison Loll/Jeff Hester (Arizona State University).

FUTURE FLIGHT

Aeronautics: New Ideas for Greener Aircraft We are accelerating the nation’s transition to the Next Generation Air Transportation System (NextGen) and making commercial aviation safer, more fuel efficient, quieter, and more environmentally friendly through investments in revolutionary concepts for air vehicles and air traffic management. Three industry teams spent 2011 studying how to meet NASA's goals for making future aircraft burn 50 percent less fuel than aircraft that entered service in 1998, emit 75 percent fewer harmful emissions; and shrink the size of geographic areas affected by objectionable airport noise by 83 percent. Image Credit: NASA

AIR FORCE SPACE BASED INFRARED SYSTEM PAYLOAD IS LAUNCHED

What Is Wrong With The Sun?

Something unexpected is happening on the Sun. 2013 was supposed to be the year of "solar maximum", the peak of the 11-year sunspot cycle. Yet 2013 has arrived and solar activity is relatively low. Sunspot numbers are well below their values from 2011, and strong solar flares have been infrequent. The quiet has led some observers to wonder if forecasters missed the mark. Conventional wisdom holds that solar activity swings back and forth like a simple pendulum. At one end of the cycle, there is a quiet time with few sunspots and flares. At the other end, solar max brings high sunspot numbers and frequent solar storms. It’s a regular rhythm that repeats every 11 years. Image Credit: NASA/SDO

SPACEX DRAGON LAUNCHES

The Launch of SpaceX Dragon KSC-2012-2913 (22 May 2012) --- On Cape Canaveral Air Force Station in Florida, Space Launch Complex-40 is ablaze as the SpaceX Falcon 9 rocket lifts off at 3:44 a.m. (EDT) May 22, 2012. The launch is the company's second demonstration test flight for NASA's Commercial Orbital Transportation Services, or COTS, program. During the flight, the Dragon capsule will conduct a series of check-out procedures to test and prove its systems, including rendezvous and berthing with the International Space Station. If the capsule performs as planned, the cargo and experiments it is carrying will be transferred to the station. The cargo includes food, water and provisions for the station's Expedition crews, such as clothing, batteries and computer equipment. Under COTS, NASA has partnered with two aerospace companies to deliver cargo to the station. Photo credit: NASA

HOME WORLD EARTH

"A 'Blue Marble' image of the Earth taken from the VIIRS instrument aboard NASA's most recently launched Earth-observing satellite - Suomi NPP. This composite image uses a number of swaths of the Earth's surface taken on January 4, 2012. The NPP satellite was renamed 'Suomi NPP' on January 24, 2012 to honor the late Verner E. Suomi of the University of Wisconsin. Suomi NPP is NASA's next Earth-observing research satellite. It is the first of a new generation of satellites that will observe many facets of our changing Earth. Suomi NPP is carrying five instruments on board. The biggest and most important instrument is The Visible/Infrared Imager Radiometer Suite or VIIRS.

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FROM: U.S. FOOD AND DRUG ADMINISTRATION

FDA Takes Steps to Strengthen Program to Assess the Safety of Chemicals in Foods, Other Products

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