M15 General Principles for Model-Informed Drug Development June 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m15-general-principles-model-informed-drug-development?utm_medium=email&utm_source=govdelivery FDA Announces the Availability of the Final Guidance "M15 General Principles for Model-Informed Drug Development" Today, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance "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 The guidance finalizes the draft guidance of the same title issued on December 30, 2024. Model-informed drug development (MIDD), which encompasses a variety of quantitative methods to help balance the risks and benefits of drug products in development, can help streamline drug development and inform regulatory decision-making. This final guidance describes the multidisciplinary principles of MIDD, including recommendations on MIDD planning, model evaluation, and evidence documentation. The guidance also includes a harmonized framework for assessing evidence derived from MIDD.