M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M15 General Principles for Model-Informed Drug Development." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance discusses the multidisciplinary principles of model-informed drug development (MIDD). This 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 The draft guidance also includes a harmonized framework for assessing evidence derived from MIDD. The draft guidance is intended to facilitate multidisciplinary understanding, appropriate use, and harmonized assessment of MIDD and its associated evidence.