Site Visit

Food and Drug Administration, Center for Drug Evaluation and Research
October 12, 2001

Author

Robin J. Strongin, Consultant

Summary

This one-day site visit to the Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) provided an overview of the approval process for prescription drugs. Specific issues examined during the visit included the impact of the Prescription Drug User Fee Act, or PDUFA, on FDA timelines and resources, post marketing surveillance, the generic drug approval process, and advertising and promotion. To help place these processes and issues in a real-world context, FDA panelists used Baycol (a cholesterol-lowering drug recently pulled from the market because of safety concerns) as a case study to describe both the pre-approval process and post-marketing surveillance. Also discussed was CDER's role in bioterrorism post–September 11.

Related Materials

No report was produced for this site visit.