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Topical corticosteroid bioequivalence

This article was originally published in The Tan Sheet

Executive Summary

FDA Generic Drugs Advisory Committee, along with representatives from the Dermatologic Drugs Advisory Committee, are scheduled to meet Sept. 12-13 to re-examine, in light of new experimental data and methods of analysis, a 1992 interim guidance issued by the Office of Generic Drugs on in vivo bioequivalence and in vitro release methods for topical corticosteroids. The committee will discuss the pharmacodynamic (i.e., vasoconstrictor) measurement of bioequivalence as well as other issues related to the documentation of equivalence, under the interim guidance. Discussion will be limited to dermatologic corticosteroids

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