21 CFR Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
- Subpart A—General Provisions (§§ 314.1 - 314.3)
- Subpart B—Applications (§§ 314.50 - 314.90)
- Subpart C—Abbreviated Applications (§§ 314.92 - 314.99)
- Subpart D—FDA Action on Applications and Abbreviated Applications (§§ 314.100 - 314.170)
- Subpart E—Hearing Procedures for New Drugs (§§ 314.200 - 314.235)
- Subpart F [Reserved]
- Subpart G—Miscellaneous Provisions (§§ 314.410 - 314.445)
- Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses (§§ 314.500 - 314.560)
- Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (§§ 314.600 - 314.650)
Authority:
21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 371, 374, 379e, 379k-1.
Link to an amendment published at 89 FR 51782, June 18, 2024.
Source:
50 FR 7493, Feb. 22, 1985, unless otherwise noted.
Editorial Note:
Nomenclature changes to part 314 appear at 69 FR 13717, Mar. 24, 2004; 81 FR 69639, Oct. 6, 2016.