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Part 312—Investigational New Drug Application

Investigational New Drug Application

Browse 21 CFR Part 312, Investigational New Drug Application requirements, one of the highest-demand CFR parts in search.

ContainsSubparts A–I
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

Editorial Note:

Nomenclature changes to part 312 appear at 69 FR 13717, Mar. 24, 2004.

Subparts

Authority21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
Source52 FR 8831, Mar. 19, 1987, unless otherwise noted.