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Briefing Date:09/25/2006
Topic:The Future of Drug Safety: Promoting and Protecting the Health of the Public

Institute of Medicine
Board on Population Health and Public Health Practice
Committee on the Assessment of the U.S. Drug Safety System


Congressional Briefings
Monday, September 25, 2006
HC-8, The Capitol Bldg. – 10:30 a.m.
2218 Rayburn House Office Bldg. – 12:00 p.m.
835 Hart Senate Office Bldg. – 1:00 p.m.
2157 Rayburn House Office Bldg. – 2:30 p.m.
2362A Rayburn House Office Bldg. – 2:30 p.m.
527 Hart Senate Office Bldg. – 2:30 p.m.
188 Dirksen Senate Office Bldg. – 4:00 p.m.
211 Dirksen Senate Office Bldg. – 4:00 p.m.



The Future of Drug Safety:
Promoting and Protecting the Health of the Public

In response to a growing public concern with health risks posed by approved drugs, the Food and Drug Administration (FDA) requested that the Institute of Medicine convene an ad hoc committee of experts to conduct an independent assessment of the current system for evaluating and ensuring drug safety post-marketing. This report considers the drug safety system as the sum of all activities conducted by FDA and other stakeholders to monitor, evaluate, improve and ensure drug safety. Recommendations are made to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

This project was funded by the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), and the Centers for Medicare & Medicaid Services (CMS).

These series of briefings were for members of Congress and congressional staff only. The report was publicly released on September 22, 2006 and can be found, in its entirety, on the Web site of the National Academies Press.

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