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# Draft Guide on Testosterone ANDA Bioequivalence
- URL: https://www.fdaweb.com/draft-guide-on-testosterone-anda-bioequivalence/
- Published: 2022-05-09T12:00:00.000Z
- Updated: 2026-09-14T17:43:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151770

*Federal Register* notice: FDA has made available a revised draft guidance entitled “Draft Guidance for Testosterone.” The document provides product-specific recommendations on the information and data needed to demonstrate bioequivalence to support ANDAs for testosterone pellets. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-05-06/pdf/2022-09737.pdf?ref=fdaweb.com).