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# FDA Publishes ICH Bioequivalence Guidance
- URL: https://www.fdaweb.com/fda-publishes-ich-bioequivalence-guidance/
- Published: 2024-07-31T12:00:00.000Z
- Updated: 2026-09-14T14:36:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157477

FDA has published the International Council for Harmonization M13A consensus guideline, *Bioequivalence for Immediate-Release Solid Oral Dosage Forms*, with recommendations on conducting bioequivalence studies during both development and post-approval phases for orally administered immediate-release solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. The [document](https://database.ich.org/sites/default/files/ICH%5FM13A%5FStep4%5FFinal%5FGuideline%5F2024%5F0723.pdf?ref=fdaweb.com) says deviations from the recommendations may be acceptable if appropriate scientific justification is provided.

The guidance includes an Introduction, General Principles in Establishing Bioequivalence, Specific Topics, Documentation, and Glossary.