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# Guide on Product-specific Bioequivalence
- URL: https://www.fdaweb.com/guide-on-product-specific-bioequivalence/
- Published: 2021-07-16T12:00:00.000Z
- Updated: 2026-09-14T17:06:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149726

*Federal Register* notice: FDA has made available a draft guidance entitled “Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam.” The document provides product-specific recommendations on the bioequivalence study designs to support ANDA submissions for such products. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-15170.pdf?ref=fdaweb.com).