What US FDA 21 CFR Part 312 - Investigational New Drug (IND) Application Requirements requires
FDA regulations at 21 CFR Part 312 govern the Investigational New Drug (IND) application process required before conducting clinical studies of unapproved drugs or approved drugs for new indications in the US…
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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/part-312
SHA-256 integrity: edab0e95a8d59e693b19fff265b0fde43089a5d43c36c376683d9ab1758e35f4
Primary Citations — 5 traced to source
- 312.20 (requirement), 312.23 (content), 312.32 (safety reports), 312.33 (annual reports) — 21 CFR Part 312 - Investigational New Drug Application
- IND content and procedural requirements — FDA Guidance for Industry: IND Applications for Clinical Investigations
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