Latest Janet Woodcock Stories

2014-07-30 16:29:10

For Accelerated Approval of Therapies for Duchenne Muscular Dystrophy WASHINGTON, July 30, 2014 /PRNewswire/ -- In response to the 106,782 signatures collected through TheRacetoYes.Org petition urging the "FDA to Say Yes to Accelerated Approval for safe, effective therapies for children with Duchenne" muscular dystrophy, the White House issued a statement yesterday by Janet Woodcock, Director, FDA Center for Drug Evaluation and Research. The Race to Yes organizers expressed...

2014-06-18 16:27:02

BETHESDA, Md., June 18, 2014 /PRNewswire-USNewswire/ -- The Parenteral Drug Association has confirmed the participation of 27 officials from the U.S. FDA, including CDER Director Janet Woodcock, MD, as speakers at the 2014 PDA/FDA Joint Regulatory Conference. Besides the Office for Drug Evaluation and Research (CDER), the FDA Centers for Biologics Evaluation and Research (CBER), Devices and Radiological Health (CDRH), and Veterinary Medicine (CVM), along with the Office of Regulatory...

2014-03-11 23:01:19

Janet Woodcock will discuss reorganization to consolidate quality-related functions. Horsham, PA (PRWEB) March 11, 2014 The U.S. Food and Drug Administration’s (FDA) Janet Woodcock will lead a discussion of the mission and function of FDA’s new Office of Pharmaceutical Quality at the DIA 2014 50th Annual Meeting in San Diego, to be held June 15 to 19. Woodcock is director of FDA’s Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription...

2013-12-20 23:00:49

ISPE studies on Drug Shortages and Quality by Design were cited by Janet Woodcock, M.D., Director of the US FDA’s Center for Drug Evaluation and Research (CDER), in her statement associated with her testimony to the U.S. Congressional Committee on Oversight and Government Reform’s Subcommittee on Energy Policy, Health Care and Entitlements. Tampa, Fla. USA (PRWEB) December 20, 2013 Two recent ISPE studies were cited by Janet Woodcock, M.D., Director of the US FDA’s Center for Drug...

FDA Tighter Controls On Hydrocodone
2013-10-25 14:26:57

Brett Smith for redOrbit.com - Your Universe Online On Thursday, the Food and Drug Administration (FDA) suggested tighter controls on how doctors prescribe common, widely-use narcotic painkillers containing the narcotic hydrocodone, making them controlled as strictly as powerful painkillers such as OxyContin. In announcing its recommendations, the FDA said it had become "increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions...

2009-11-25 16:00:00

SILVER SPRING, Md., Nov. 25 /PRNewswire-USNewswire/ -- An article by Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, titled "A Difficult Balance - Pain Management, Drug Safety, and the FDA," appears in the Nov. 26, 2009 issue of The New England Journal of Medicine. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) In the article, Woodcock discusses FDA efforts to strike a balance between access to pain medication for those who need it and...

2009-07-01 12:40:30

The U.S. Food and Drug Administration announced Wednesday it will require a boxed warning for the smoking cessation drugs Chantix and Zyban. The FDA said the boxed warning -- the strongest warning the agency can require -- will appear on the package insert. It will highlight the risk of serious mental health events, including changes in behavior, depressed mood, hostility and suicidal thoughts when taking the drugs. The risk of serious adverse events while taking these products must be...

2006-02-14 17:11:16

By Lisa Richwine WASHINGTON (Reuters) - Scientists will search for better and earlier signs that a patient is likely to respond to a cancer-fighting drug, or suffer toxic side effects, under a U.S. program announced on Tuesday. Three federal agencies will join together to identify biological indicators, or "biomarkers," that can be analyzed in blood, tissue or other samples, or through imaging scans. Biomarkers already are part of drug development, but health officials said they...

Word of the Day
  • Like a worm in form or movement; vermiform; tortuous or sinuous; also, writhing or wriggling.
  • Like the track or trace of a worm; appearing as if worm-eaten; vermiculate.
  • Marked with fine, close-set, wavy or tortuous lines of color; vermiculated.
  • A form of rusticated masonry which is so wrought as to appear thickly indented with worm-tracks.
This word ultimately comes from the Latin 'vermis,' worm.