Biomedical Science & Policy Discussion Series
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.