Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbrevi
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
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-05-29 |
| Summary | 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 This guidance finalizes the draft guidance for industry of the same title issued on August 23, 2021. |
| Document number | 2026-10703 |
| Official record | https://www.federalregister.gov/documents/2026/05/29/2026-10703/bioequivalence-studies-with-pharmacokinetic-endpoints-for-drugs-submitted-under-an-abbreviated-new |