What 21 CFR Part 312 - Investigational New Drug Application requires
This regulation establishes the requirements for submitting and maintaining an Investigational New Drug…
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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: 38415f60254747fea8fb9650ee53bbdab3c19ebacf0e702dd9e1cd6c94ef12a6
Primary Citations — 9 traced to source
- § 312.20 Requirement for an IND.
- § 312.23 IND content and format.
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