M15 General Principles for Model-Informed Drug Development; International Council for Harm
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 Pharmaceutical
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-06-03 |
| Summary | 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, |
| Document number | 2026-11112 |
| Official record | https://www.federalregister.gov/documents/2026/06/03/2026-11112/m15-general-principles-for-model-informed-drug-development-international-council-for-harmonisation |