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UCSF-CDDS 2007 Role of FDA in Guiding Drug Development Carl Peck Center for Drug Development Science UCSF, UC-Washington Center Washington DC ? Why FDA ? When does FDA get involved ? How does FDA guide drug development? What comprises FDA guidance ? What’s new at FDA ? Guiding Drug DevelopmentWhy FDA? FDC Act: history and its supporters resulted from public safety events or public health challenges ~ 1902/6, 1938, 1962, 1972, 1987, 1997, 2004 a uniquely American phenomenon Evolution of Drug Regulation (R. Temple) When does FDA get involved ? Preclinical (voluntary) phase animal testi