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# Comments on Drug Interaction Study Guidance
- URL: https://www.fdaweb.com/comments-on-drug-interaction-study-guidance/
- Published: 2022-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:01:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152846

PTC Therapeutics says the International Council for Harmonization M12 draft guidance on drug interaction studies provides general guidelines on how to design, conduct, and interpret drug-drug interaction studies during the development of a therapeutic product. In a comment [letter](https://www.regulations.gov/comment/FDA-2022-D-1527-0004?ref=fdaweb.com), PTC makes suggestions and seeks clarifications on ICH harmonized guidelines vs. FDA guidance and six technical topics.

An AstraZeneca comment [letter](https://www.regulations.gov/comment/FDA-2022-D-1527-0003?ref=fdaweb.com) describes the document as “well-balanced guidance, summarizing the general state of knowledge and best practice.” It also provides specific line-by-line comments.