Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human Trials; Draft Guidance for Industry; Availability
🏛 Food and Drug Administration (FDA)FDA-2026-D-6539
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3
Total comments
17
16 awaiting analysis
Comment status
Open
Last activity
Jul 24, 2026
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Documents
Rules, notices, and supporting material — the primary rule pinned first.
- Notice· Jun 24, 2026Closed on Jul 25, 2026