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French senators reject a bill on sedating terminal patients

June 23, 2015 11:37 am | by Associated Press | News | Comments

France's senate has voted against a bill allowing the sedation of terminally ill patients, fearing it would lead to allowing euthanasia, which is illegal in the country. Senators in Paris rejected the law by a vote of 196-87.

NIH suspends experimental drug production

June 5, 2015 6:20 am | by Associated Press | News | Comments

Thursday's suspension leaves about 250 people in 46 NIH studies waiting to hear when they will...

Appalachia gripped by hepatitis C epidemic

June 5, 2015 6:12 am | by Claire Galofaro, AP | News | Comments

The CDC has found that hepatitis C cases across four Appalachian states more than tripled...

Anthrax shipments came from desert military base

May 29, 2015 10:50 am | by BRADY McCOMBS, ROBERT BURNS, Associated Press | News | Comments

The U.S. Army's mistaken shipment of live anthrax samples to government and commercial...

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Obama Says Ebola-Fighting Goal is to Prevent Any New Cases

April 15, 2015 2:51 pm | by The Associated Press | News | Comments

President Barack Obama is citing major gains in fighting the Ebola outbreak in West Africa and says the goal now is to prevent any new cases.

Hospira gets FDA Warning

April 7, 2015 4:17 pm | by AP | News | Comments

Drug and medical device maker Hospira said that it received a warning letter from the FDA following an Italian factory inspection. The agency said it found problems with procedures that are supposed to prevent sterile products from being contaminated, and found fault with Hospira's inspections procedures. It also said the company should have better security protecting data generated during its manufacturing process.

American with Ebola is Improving

April 7, 2015 4:12 pm | by AP | News | Comments

Officials say an American healthcare worker who contracted Ebola while volunteering in Sierra Leone has improved to good condition at a federal hospital. He is being treated at the NIH hospital in Bethesda, Maryland.

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HHS Contracts to Develop New Ebola Drug

March 31, 2015 11:54 am | by U.S. Department of Health & Human Services | News | Comments

HHS awarded approximately $12 million today to BioCryst Pharmaceuticals of Durham, North Carolina, for the advanced development of a promising experimental drug for Ebola, including preparing for large-scale manufacturing of the drug and conducting related studies.

Audit: Maryland Misallocated $28.4M for Health Exchange

March 30, 2015 1:19 pm | by Brian Witte, The Associated Press | News | Comments

Maryland misallocated $28.4 million in federal money for its flawed health care exchange and should pay the money back, according to a federal audit set to be released Friday.

FDA Issues Final Rule on Changes to Pregnancy and Lactation Labeling Info for Rx Drug and Biological Products

December 3, 2014 11:43 am | News | Comments

The FDA published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.

FDA Issues Additional Guidance for Outsourcing Facilities That Compound Sterile Human Drugs

November 24, 2014 1:18 pm | News | Comments

The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the DQSA, which was enacted in November 2013.

FDA Panel Votes to Keep Boxed Warning on Chantix

October 16, 2014 4:36 pm | by The Associated Press | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning.

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Allergan's OZURDEX® Receives European Positive Opinion for the Treatment of Diabetic Macular Edema

July 25, 2014 8:03 am | News | Comments

Allergan announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorization for OZURDEX ® (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular edema.

FDA Warns About Dangers of Caffeine Powder

July 22, 2014 9:10 am | Videos | Comments

The medical alert came after an Ohio teen died from a caffeine overdose days before his high school graduation.                       

FDA Issues Draft Information Sheet Guidance on Informed Consent

July 16, 2014 11:42 am | News | Comments

This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent.      

FDA Outlines Expectations for Drug Compounders, Including Outsourcing Facilities

July 1, 2014 11:56 am | News | Comments

Today, the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy consists of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.

FDA Says Babies Don't Need Teething Medicines

June 27, 2014 9:07 am | News | Comments

Too often well-meaning parents, grandparents and caregivers want to soothe a teething baby by rubbing numbing medications on the tot's gums, using potentially harmful drugs instead of safer, non-toxic alternatives.      

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FDA Issues Guidance to Support the Responsible Development of Nanotechnology Products

June 25, 2014 7:57 am | News | Comments

Three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.         

FDA to Require Warnings on Sunlamp Products

May 29, 2014 2:21 pm | News | Comments

The FDA has issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices.          

EMA Reports Vials of Falsified Herceptin Identified

April 16, 2014 8:41 am | News | Comments

The European Medicines Agency (EMA) has been informed that vials of the cancer medicine Herceptin (trastuzumab), thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries.

Facility Concerns Kill Lilly-Boehringer Diabetes Drug

March 5, 2014 11:05 am | News | Comments

Eli Lilly and Boehringer-Ingelheim said  that the Food and Drug Administration didn't approve their diabetes treatment empagliflozin because of concerns about a facility where the drug will be made.        

Meet – “That Guy”

December 18, 2013 3:55 pm | by Mike Auerbach, Editor in Chief | Blogs | Comments

I’m the guy who looks down his nose at every new health trend and scoffs at those who embark on low-carb diets or overindulging on pomegranates or chugging wheat grass juice or slathering their hands with anti-bacterial soap, or downing multi-vitamins and supplements like Halloween candy.

FDA Warns of Dangerous Erections from ADHD Drugs

December 17, 2013 3:35 pm | by The Associated Press | News | Comments

The Food and Drug Administration is warning that a stimulant used in treatments for the childhood condition attention deficit-hyperactivity disorder can trigger painful, long-lasting erections in rare cases.       

FDA Takes Significant Steps to Address Antimicrobial Resistance

December 11, 2013 11:59 am | News | Comments

The U.S. Food and Drug Administration is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.

Class Action Suit Filed Against ARIAD Pharmaceuticals

November 22, 2013 10:29 am | by Associated Press | News | Comments

This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws.                                       

Another Study Bullish On Novartis Blood Pressure Drug

October 31, 2013 10:45 am | News | Comments

The Shiga University of Medical Science has become the third Japanese institution to conclude that a clinical study report on Novartis Pharma K.K.'s Diovan blood pressure-lowering drug contained doubtful data and was inappropriate, largely because a Novartis employee participated in the study.

FDA Seeks Pet Owner Help on Dangerous Jerky Treats

October 23, 2013 8:45 am | News | Comments

The Food and Drug Administration is appealing to dog and cat owners for information as it struggles to solve a mysterious outbreak of illness and deaths among pets that ate jerky treats. In a notice to consumers and veterinarians published Tuesday, the agency said it has linked illnesses from jerky pet treats to 3,600 dogs and 10 cats since 2007. About 580 of those pets have died.

FDA Strengthens Warnings for Arzerra and Rituxan

September 26, 2013 8:41 am | News | Comments

The FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection.

FDA Warns Pregnant Women of Migraine Drug Risk

May 7, 2013 8:17 am | by MATTHEW PERRONE,AP Health Writer | News | Comments

U.S. health regulators are warning doctors and women of child-bearing age that half-a-dozen medications used to treat migraine headaches can decrease children's intelligence if taken while their mothers are pregnant. The Food and Drug Administration said Monday that the drugs, including Depakote and Depacon, should never be taken by pregnant women for the prevention of migraine headaches.

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