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Regulations last checked for updates: May 15, 2025

Title 21 - Food and Drugs last revised: May 12, 2025
All TitlesTitle 21Chapter IPart 312 - PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
  • Subpart A [§ 312.1 - § 312.10] - Subpart A—General Provisions
  • Subpart B [§ 312.20 - § 312.38] - Subpart B—Investigational New Drug Application (IND)
  • Subpart C [§ 312.40 - § 312.48] - Subpart C—Administrative Actions
  • Subpart D [§ 312.50 - § 312.70] - Subpart D—Responsibilities of Sponsors and Investigators
  • Subpart E [§ 312.80 - § 312.88] - Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
  • Subpart F [§ 312.110 - § 312.145] - Subpart F—Miscellaneous
  • Subpart G [§ 312.160 - § 312.160] - Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
  • Subpart H - Subpart H [Reserved]
  • Subpart I [§ 312.300 - § 312.320] - Subpart I—Expanded Access to Investigational Drugs for Treatment Use
source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.
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