The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA." This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. This guidance finalizes the draft guidance for industry of the same title issued on August 23, 2021.
US Federal Register - FDA Guidance Notices · May 29, 2026
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry
Original title: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability
FDA finalizes guidance on bioequivalence study requirements for generic drug applications under the ANDA pathway.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.