FDA publishes the final guidance for industry, “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence”

On July 13, 2026, FDA published the final guidance for industry titled “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.” This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroid products (topical corticosteroids) and describes recommendations for in vivo studies to demonstrate the bioequivalence (BE) of topical corticosteroids.