Margaret Hamburg, M.D., Commissioner, US Food and Drug Administration; Carolyn Clancy, M.D., Director, Agency for Healthcare Research and Quality, Jeffrey Shuren, M.D., JD, Director, Center for Devices and Radiological Health, US Food and Drug Administration; Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, US Food and Drug Administration; Joe V. Selby, M.D., MPH, Executive Director, Patient-Centered Outcomes Research Institute; and Karen Ignagni,

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.

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.

A top U.S. Food and Drug Administration official reportedly has refused to support Democrats on tougher inspection plans.

The Food and Drug Administration said Monday that contaminated heparin, a blood thinner, has been detected in 11 countries and that the number of U.S. deaths potentially linked to the contamination has risen to 81, up from 62.