Code of Federal Regulations > Title 21 > Chapter I > Part 312 - PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

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