Author: [AUTHOR] Published on 1/10/2025 12:00:00 AM
FDA Announces the Availability of a Draft Guidance - M15 General Principles for Model-Informed Drug Development
On December 30, 2024, the US Food and Drug Administration (FDA) announced the availability of a draft guidance
M15 General Principles for Model-Informed Drug Development. Developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), this draft guidance discusses the multidisciplinary principles of model-informed drug development (MIDD) and provides recommendations on MIDD planning, model evaluation, and evidence documentation.
Drug development is a sequential and iterative process where MIDD can play an important strategic role. Appropriate use of MIDD can enable greater efficiency in drug development, while harmonized approaches to assessment can promote consistent and transparent evaluation of MIDD evidence to inform regulatory decision-making. The draft guidance discusses the multidisciplinary principles of MIDD and includes recommendations on MIDD planning, model evaluation, and evidence documentation. The draft guidance also includes a harmonized framework for assessing evidence derived from MIDD. The draft guidance is intended to facilitate multidisciplinary understanding, appropriate use, and harmonized assessment of MIDD and its associated evidence. This guidance does not include details regarding technical aspects of model development. Model development should follow the general recommendations outlined in this guidance in conjunction with current accepted standards and/or scientific practices for specific modeling and simulation methods.
FDA is publishing this draft guidance to collect additional public comments. You may submit your comments regarding the draft guidance to the docket (Docket No.
FDA-2024-D-5580.) available at
https://www.regulations.gov up to 60 days following publication in the FEDERAL REGISTER. This guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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