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Last updated on April 18, 2014 at 17:24 EDT

Latest Janet Woodcock Stories

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...

2013-03-04 20:22:46

ATLANTA, March 4, 2013 /PRNewswire-USNewswire/ -- The Arthritis Foundation will present Janet Woodcock, M.D. of the FDA with the Floyd B. Odlum Making a Difference Award at the annual Advocacy Summit in Washington, D.C. this week. The national award is presented annually and honors an individual, organization, corporation or government agency that has helped to make a difference in the lives of people and families with arthritis. Dr. Woodcock is recognized for her exceptional service to...

2011-10-05 10:54:00

FDA's Hamburg, AHRQ's Clancy, and Others Address Policy, Practice, Health Law, Informed Consent, and More PLYMOUTH MEETING, Pa., Oct. 5, 2011 /PRNewswire-USNewswire/ -- The term "patient-centeredness" is now enshrined in law by the Affordable Care Act, which created the new Patient Centered Outcomes Research Institute. Patient-centeredness is increasingly embedded in program developments at the federal and state level, and in the private sector, too. But what does patient-centeredness...

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...

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2006-01-19 07:25:00

FDA action is designed to help doctors and consumers, officials say U.S. health officials announced Wednesday a major overhaul of the package inserts that accompany prescription drugs. It's hoped that the changes, designed to be easier to read and understand, will benefit not only doctors and other health-care workers, but consumers as well, officials said at a news conference. "We see this as a platform whereby we can build much better consumer information," said Dr. Janet Woodcock, deputy...