FDA Announces Improved Policies for Advisory Committees

On August 4, 2008, the Food and Drug Administration announced several improved policies and procedures strengthening its management of FDA advisory committees. FDA advisory committees are panels of independent, outside experts — often the world’s leading authorities in their fields — who advise agency officials as they consider regulatory decisions involving complex medical and scientific issues. FDA may pose questions to an advisory committee about a specific product. The advisory committee discusses the questions after reviewing briefing materials that contain background information such as available clinical studies and then votes on the questions presented by FDA. Although the committee makes recommendations to FDA, the agency makes the final decisions.


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