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Part 314—Applications for FDA Approval to Market a New Drug

Applications for FDA Approval to Market a New Drug

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

PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Editorial Note:

Nomenclature changes to part 314 appear at 69 FR 13717, Mar. 24, 2004; 81 FR 69639, Oct. 6, 2016.

Subparts

Authority21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.
Source50 FR 7493, Feb. 22, 1985, unless otherwise noted.