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Regulations last checked for updates: Dec 18, 2025
Title 21 - Food and Drugs last revised: Dec 12, 2025
All Titles
Title 21
Chapter I
Part 312-INVESTIGATIONAL - 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
authority:
21 U.S.C. 321
,
331
,
351
,
352
,
353
,
355
,
360bbb
,
371
;
42 U.S.C. 262.
source:
52 FR 8831, Mar. 19, 1987, unless otherwise noted.
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