Issue Date: May 29, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Biopharmaceutics, Generic Drugs
Status: Final
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled “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 This guidance finalizes the draft guidance for industry of the same title issued on August 23, 2021.
Download the Guidance Document
