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 The Institute of Medicine (IOM)
Forum on Drug Discovery, Development, and Translation
Presents the Fourth Meeting in the Forum’s
Biomedical Science & Policy Discussion Series

SCIENCE AT FDA: CHALLENGES AND OPPORTUNITIES

April 21, 2008 10:00 a.m. – 3:30 p.m.
National Academy of Sciences, Keck Center, Room 100
500 5th Street, NW, Washington, DC

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As the principal agency responsible for regulating the nation’s food, dietary supplements, drugs, vaccines, medical devices, diagnostics, and cosmetics, the Food and Drug Administration (FDA) has an enormous responsibility for protecting the health of the nation. Emerging technologies in genomics, nanotechnology, systems biology, cell-based technologies, regenerative medicine, genetically-modified foods, informatics, and other areas have created new opportunities, and have, at the same time, yielded complex new products and created a rapidly shifting technology landscape. The ability of the FDA to adapt to this changing landscape and embrace innovation in fulfilling its mission of food and drug regulation is critical. The purpose of this meeting was to provide an opportunity for experts and stakeholders representing diverse perspectives—academia, industry, government, patients, and others—to examine the current scientific capacities of the FDA, to explore the opportunities and challenges inherent in the changing scientific landscape; and to consider the steps that can be taken to ensure that the FDA is equipped to meet these challenges in the future.

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