HHS FDA Issues Final Guidance on Bioequivalence Studies for Generic Drug Applications
June 02, 2026
June 02, 2026
WASHINGTON, June 2 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a final guidance for industry outlining recommendations for bioequivalence studies that use pharmacokinetic endpoints in support of abbreviated new drug applications, amendments and supplements. The guidance, announced in the Federal Register on May 29, 2026, is intended to help applicants meet bioequivalence requirements established under the Federal Food, Drug, and Cosmetic Ac . . .