Tip Sheets

Advances in FDA’s Drug Safety Program (Janet Woodcock presentation)

Panel: Newsmaker briefing: Advances in how FDA monitors drug safety after approval (Health Journalism 2012)

Speaker: Janet Woodcock, M.D., director, FDA Center for Drug Research and Evaluation

PDF of presentation

Panel description: Groundbreaking legislation under the Food and Drug Administration Amendments Act went into effect in 2008, authorizing major changes in how the safety of drugs would be monitored once they were already on the market. The move followed several highly publicized drug safety issues in the early to mid-2000s. After four years, the FDA is releasing a new report detailing where it stands on its goals and capabilities to enhance drug safety for the American public.