Topic: Janet Woodcock
On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, a single-shared risk evaluation and mitigation strategy (REMS) for transmucosal...
Pressure to spur development of new medical products, deal with an increasingly global pharmaceutical supply chain, and accomplish more tasks with...
New drug approvals are on track to breach levels last seen at the turn of the 21st century (observe chart below). Midway through 2011, the Food &...
The Food and Drug Administration is seeking insight from doctors and others in health care on how best to prevent the harms associated with misuse of medications.. As part of its "Safe Use Initiative," the FDA is targeting injection safety as well ...
Colds and coughs are a challenge for adults but when children are experiencing colds and coughs, parents want to give them relief as soon as possible. The recommendation came as part of a chain reaction of pressure on drug companies by the ...
FDA has determined to significantly restrict the use of formulations that contain rosiglitazone (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline [GSK]) to patients with Type 2 diabetes who cannot control their diabetes with other medications. FDA is also requiring GSK to commission an independent ...
By clarifying rules governing patient access to so-called investigational drugs, U.S. health officials said Wednesday that they hope to expand the number of people who might benefit from these not-yet-approved medications.. Both Woodcock and Dee spoke at a Wednesday news conference ...
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, is under investigation for an alleged conflict of interest, the WSJ reports. The FDA said it is aware of the allegations, and did not make Woodcock available for comment ...
Concerns about the possibility of fatal overdoses led U.S. health officials Tuesday to take several steps to limit the risk of using pain medications containing propoxyphene, including Darvon and Darvocet.. The manufacturers must also conduct a new safety study to assess ...
7/7/2009 Print E-mail Concerns about the possibility of fatal overdoses led U.S. health officials Tuesday to take several steps to limit the risk of using pain medications containing propoxyphene, including Darvon and Darvocet.. The manufacturers must also conduct a ...
Video Gallery
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Dr. Janet Woodcock of FDA on ...
FDA/USP co-sponsored workshop on over-the-counter (OTC) medicines. FDA's ...2011-09-10 -
FDA comments on the intimidation of ...
Janet Woodcock, CDER Director, comments on the recent increase in ...2010-11-20 -
SmartTots to Help Make Anesthetics and ...
Dr. Janet Woodcock, director of the Center for Drug Evaluation ...2011-03-05
