Executive Summary

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. . . .