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# Guidance on Bioequivalence Testing Samples
- URL: https://www.fdaweb.com/guidance-on-bioequivalence-testing-samples/
- Published: 2024-03-27T12:00:00.000Z
- Updated: 2026-09-14T14:26:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156647

*Federal Register* notice: FDA is making available a guidance entitled “Handling and Retention of BA and BE Testing Samples.” The document provides recommendations for NDA/ANDA application holders regarding the procedures for handling reserve samples from relevant bioavailability and bioequivalence studies. It also includes recommendations on the responsibilities of each party involved in the study pertaining to reserve samples. Additionally, the guidance describes the conditions under which the agency generally does not intend to take enforcement action against an applicant who retains less than the quantity of reserve samples specified in the regulation. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-03-27/pdf/2024-06500.pdf?ref=fdaweb.com).