21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION
- Subpart A—General Provisions (§§ 312.1 - 312.10)
- Subpart B—Investigational New Drug Application (IND) (§§ 312.20 - 312.38)
- Subpart C—Administrative Actions (§§ 312.40 - 312.48)
- Subpart D—Responsibilities of Sponsors and Investigators (§§ 312.50 - 312.70)
- Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses (§§ 312.80 - 312.88)
- Subpart F—Miscellaneous (§§ 312.110 - 312.145)
- Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests (§ 312.160)
- Subpart H [Reserved]
- Subpart I—Expanded Access to Investigational Drugs for Treatment Use (§§ 312.300 - 312.320)
Source:
52 FR 8831, Mar. 19, 1987, unless otherwise noted.
Editorial Note:
Nomenclature changes to part 312 appear at 69 FR 13717, Mar. 24, 2004.