M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; International Council for Harmonisation; Draft Guidance for Industry; Availability
🏛 Food and Drug Administration (FDA)FDA-2025-D-2275
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Rules, notices, and supporting material — the primary rule pinned first.
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OtherJan 21, 2026
M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft GuidanceClosed on Mar 24, 2026