FDA to issue revised clinical protocols to establish bioequivalence for topical antifungals, vaginal antifungals and tretinoin in 30 days, Office of Generic Drugs Acting Director Bruce Burlington, MD, told a Nov. 16 FDA workshop. The agency will review material presented at the workshop and issue revised protocols, which may be open for further comment. Industry members asked FDA to provide a definition of bioequivalence for topical antifungals; the acceptable confidence interval for response in clinical trials; and clearly defined clinical endpoints. A draft bioequivalence protocol was issued at the meeting and is available through the agency. . . .
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