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FDA's Generic Drugs Advisory Committee

This article was originally published in The Rose Sheet

Executive Summary

Agenda for the panel's Sept. 12-13 meeting is amended to include presentation of pilot data on "development of pharmacodynamic and pharmacokinetic assays to demonstrate tretinoin bioequivalence," according to an Aug. 19 Federal Register notice. The agenda for the meeting already includes a re- examination of the July 1992 Interim Guidance for Topical Corticosteroids and discussions on pharmacodynamic measurement bioequivalence. The meeting will be held in Conference Rooms G-J of FDA's Parklawn Building, 5600 Fishers Lane, Rockville, MD beginning at 8:30 a.m. on both days
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