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FDA Generic Drugs Advisory Committee

Executive Summary

Agenda for Sept. 12-13 meeting includes a re-examination of the July 1992 Interim Guidance for Topical Corticosteroids: In Vivo Bioequivalence and In Vitro Release Methods," July 27 Federal Register notice states. The committee, with representation from FDA's Dermatologic Drugs Advisory Committee, will discuss pharmacodynamic (vasoconstrictor) measurement of bioequivalence on both days. On Sept. 13, the committee will consider other issues related to the documentation of equivalence according to the interim guidance. Discussion will be limited to dermatologic products and will not include ophthalmic or inhaled corticosteroid products." The meeting will be held in Conference Rooms G-J in FDA's Parklawn Building beginning at 8:30 a.m. both days

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