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# M12 Drug Interaction Q&A
- URL: https://www.fdaweb.com/m12-drug-interaction-q-a/
- Published: 2024-08-01T12:00:00.000Z
- Updated: 2026-09-14T14:37:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157483

FDA has published an International Council on Harmonization (ICH) guidance, *M12 Drug Interaction Studies Questions and Answers*, to respond to questions posted to the ICH draft guidance comment period. The [document](https://www.fda.gov/media/180488/download?ref=fdaweb.com) says it was developed to provide clarity around some of the concepts related to the evaluation of drug interactions covered in the guidance.

The Guidance includes an Introduction, In Vitro Evaluation, Clinical Evaluation, Reporting and Interpreting Clinical Drug-Drug Interaction Study Results, and an Appendix.