What Investigational New Drug Application: IND Content, Phases of Investigation, Safety Reporting and Annual Reports requires
This regulation requires sponsors of investigational new drugs to submit an Investigational New Drug Application (IND) to the FDA, as outlined in 21 CFR 312.20-312.33, and to conduct investigations in accordance with 21 CFR 312.50-312.53.
Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312
SHA-256 integrity: 1f124c4ef259fcdce33d9335edec34b79d11d64a0d7c13f68090d91a2c033235
Primary Citations — 8 traced to source
- 21 CFR 312.20: General provisions
- 21 CFR 312.21: Phases of an investigation
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