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GUIDANCE DOCUMENT

M12 Drug Interaction Studies August 2024

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2022-D-1527
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance for industry entitled “M12 Drug Interaction Studies” and the supplemental document entitled “M12 Drug Interaction Studies:  Questions and Answers.”  The guidance and supplemental questions and answers document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).  The guidance provides general recommendations on evaluating the enzyme and transporter-mediated pharmacokinetic drug-drug interaction potential for investigational drugs.  The supplemental questions and answers document provides clarity to some concepts related to evaluation of drug interactions covered in the guidance.  The guidance is intended to harmonize the regional recommendations for designing, conducting, and interpreting in vitro and clinical evaluations of drug-drug interactions while developing investigational drugs.  The guidance replaces the draft guidance “M12 Drug Interaction Studies” issued on August 29, 2022.

M12 Drug Interaction Studies: Questions and Answers

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All written comments should be identified with this document's docket number: FDA-2022-D-1527.

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