← FDA GUIDANCE
FDA GUIDANCE · FINALJune 2, 2026

M15 General Principles for Model-Informed Drug Development

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Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status
Final
Topic
New Approach Methodologies, ICH-Multidisciplinary
Issue date
June 2, 2026
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