Federal Register #FDA2024D5580

FDA Final Guidance: Model-Informed Drug Development Principles

This notice from the Food and Drug Administration (FDA) provides industry guidance on model-informed drug development (MIDD). - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Guidance Details: - Final guidance titled "M15 General Principles for Model-Informed Drug Development" - Developed under the International Council for Harmonisation (ICH) - Offers recommendations for planning, evaluating, and documenting evidence from MIDD - Establishes a harmonized assessment framework for regulatory interactions, reporting, and submission - Aims to facilitate multidisciplinary understanding of MIDD - Notable Requirements: - No products, OEMs, or purchase quantities are requested - Notice is informational and not a procurement opportunity

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance for industry entitled "M15 General Principles for Model-Informed Drug Development." Prepared under the International Council for Harmonisation (ICH), the guidance provides recommendations for planning, evaluating, and documenting evidence from model-informed drug development (MIDD). It establishes a harmonized assessment framework and offers guidance on regulatory interactions, reporting, and submission to facilitate multidisciplinary understanding of MIDD. This guidance finalizes the draft issued on December 30, 2024.

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