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# Improve ICH M13A Bioequivalence Guidance: PhRMA
- URL: https://www.fdaweb.com/improve-ich-m13a-bioequivalence-guidance-phrma/
- Published: 2023-04-11T12:00:00.000Z
- Updated: 2026-09-14T18:25:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154182

Pharmaceutical Research and Manufacturers of America (PhRMA) says that while it supports the general development of the International Council for Harmonization M13A draft guidance on bioequivalence for immediate-release solid oral dosage forms, it sees several opportunities to improve the draft. The PhRMA comment [letter](https://downloads.regulations.gov/FDA-2023-D-0093-0005/attachment%5F1.pdf?ref=fdaweb.com) suggests ways to clarify the document’s recommendations to support consistent interpretation by regulatory authorities across regions. It also recommends that certain sections better incorporate risk-based approaches to help avoid unnecessary patient exposure and bioequivalence studies that would not add value.