What 21 CFR Part 312 - Investigational New Drug Application requires
This regulation establishes the requirements for submitting and maintaining an Investigational New Drug Application (IND), detailing the responsibilities of sponsors and investigators in conducting clinical trials.
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
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Primary Citations — 9 traced to source
- § 312.20 Requirement for an IND.
- § 312.23 IND content and format.
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