What US 21 CFR Part 312: Investigational New Drug Application requires
US 21 CFR Part 312 sets requirements for the Investigational New Drug (IND) application process governing clinical investigation of drugs and biologics in humans. The regulation covers IND content (Forms FDA 1571 and 1572, protocols, nonclinical studies, CMC, prior human experience), 30-day FDA review with automatic safe-to-proceed clearance, sponsor responsibilities including IND safety reports and annual reports, investigator responsibilities, FDA clinical hold authority, and emergency expanded access (compassionate use). Compliance is foundational to every drug clinical trial in the US.
Pillar: Pharmaceuticals & Life Sciences · Authority: US Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312
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Primary Citations — 5 traced to source
- Title 21 Code of Federal Regulations Part 312 Investigational New Drug Application
- Title 21 Code of Federal Regulations Part 50 Protection of Human Subjects
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