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HHS FDA Finalizes International Guidance on Model-Informed Drug Development
June 04, 2026
WASHINGTON, June 4 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has announced the availability of a final guidance titled "M15 General Principles for Model-Informed Drug Development," establishing an internationally harmonized framework for the planning, evaluation and documentation of evidence generated through model-informed drug development. The guidance was developed through the International Council for Harmonisation of Technical Require . . .

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