What Investigational New Drug Application requires
This regulation establishes the requirements for submitting an Investigational New Drug (IND) application to the FDA, including content, safety…
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Pillar: Pharmaceuticals & Life Sciences · Authority: Food and Drug Administration, Department of Health and Human Services · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312
SHA-256 integrity: 0e56aef8d2be9a841f09abadb99c36e24c2d480488bed3bad81883fdae7f86b5
Primary Citations — 7 traced to source
- 21 CFR § 312.23 - IND content and format
- 21 CFR § 312.30 - Protocol amendments
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- Discovery (free): /api/v1/nodes/us-fda-21-cfr-312-ind-application.json — 6-field metadata
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