HHS FDA Issues Final Guidance on Statistical Approaches to Bioequivalence Studies
June 02, 2026
June 02, 2026
WASHINGTON, June 2 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced the availability of a final guidance for industry titled "Statistical Approaches to Establishing Bioequivalence," updating recommendations for sponsors and applicants conducting bioequivalence studies in support of drug development and approval applications.
The guidance applies to investigational new drug applications, new drug applications, abbreviate . . .
The guidance applies to investigational new drug applications, new drug applications, abbreviate . . .