Subscribe to Advisories

The Lead

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...

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...

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...

View Sample

FREE Email Newsletter

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.

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.      

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.

Health and Human Services Budget to Get a 5.4% Increase in Obama's 2014 budget

April 10, 2013 1:42 pm | by The Associated Press | News | Comments

President Barack Obama has proposed a $3.8 trillion budget for fiscal 2014 that aims to slash the deficit by $1.8 trillion over 10 years, raise taxes on the wealthy and trim popular benefit programs including Social Security and Medicare. The numbers do not reflect automatic annual spending cuts of 5 percent for domestic agencies and 8 percent for defense.

Official: Obama to Announce Brain Mapping Project

April 2, 2013 8:10 am | by NEDRA PICKLER,Associated Press | News | Comments

President Barack Obama is proposing a new investment into research to map the human brain in hopes of unlocking some of its mysteries, a senior administration official says. The president planned to propose a $100 million investment for next year during an announcement at the White House Tuesday morning, the official said.

Panel Questions Value of Calcium, Vitamin D Pills

February 27, 2013 8:01 am | by LAURAN NEERGAARD,AP Medical Writer | News | Comments

Popping calcium and vitamin D pills in hopes of strong bones? Healthy older women shouldn't bother with relatively low-dose dietary supplements, say new recommendations from a government advisory group. Both nutrients are crucial for healthy bones and specialists advise getting as much as possible from a good diet.

Dynavax Tumbles as FDA Asks for More Heplisav Data

February 25, 2013 12:49 pm | News | Comments

Shares of Dynavax Technologies Corp. fell by more than a third after the company said the Food and Drug Administration won't approve its hepatitis B vaccine Heplisav unless Dynavax provides more information showing the drug is safe. Dynavax said the FDA is concerned about the possibility of "rare autoimmune events" in patients. 

You may login with either your assigned username or your e-mail address.
The password field is case sensitive.