FDA's Generic Drugs Advisory Committee

Executive Summary

Has scheduled a Sept. 26-27 meeting to discuss pharmacokinetic and statistical issues involved in determining bioequivalence. Reportedly, the panel will also discuss the idea of an FDA monograph system for generic drugs. On the first day, the committee will consider the rate and extent of absorption; on the second day, the panel will discuss "data transformation, sequence effect, and outlier analysis," an Aug. 20 Federal Register notice states. The meeting will begin at 8 a.m. each day at the Ramada Inn, Embassy Ballroom, 8400 Wisconsin Avenue, Bethesda, Md.