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GUIDANCE DOCUMENT

M15 General Principles for Model-Informed Drug Development June 2026

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2024-D-5580
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “M15 General Principles for Model-Informed Drug Development.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides general recommendations for the planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD). It establishes a harmonized assessment framework (including the associated terminology) for the MIDD evidence. It also provides recommendations for related regulatory interactions, reporting, and submission. This guideline is intended to facilitate a multidisciplinary understanding of MIDD and associated evidence generation. The guidance finalizes the draft guidance of the same title issued on December 30, 2024.

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-5580.

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