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Regulations last checked for updates: May 22, 2025
Title 21 - Food and Drugs last revised: May 19, 2025
All Titles
Title 21
Chapter I
Part 314 - PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart A [§ 314.1 - § 314.3] - Subpart A—General Provisions
Subpart B [§ 314.50 - § 314.90] - Subpart B—Applications
Subpart C [§ 314.92 - § 314.99] - Subpart C—Abbreviated Applications
Subpart D [§ 314.100 - § 314.170] - Subpart D—FDA Action on Applications and Abbreviated Applications
Subpart E [§ 314.200 - § 314.235] - Subpart E—Hearing Procedures for New Drugs
Subpart F - Subpart F [Reserved]
Subpart G [§ 314.410 - § 314.445] - Subpart G—Miscellaneous Provisions
Subpart H [§ 314.500 - § 314.560] - Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
Subpart I [§ 314.600 - § 314.650] - Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
authority:
21 U.S.C. 321
,
331
,
351
,
352
,
353
,
355
,
355
a,
355
f,
356
,
356
a,
356
b,
356
c,
356
e,
360cc
,
371
,
374
,
379e
,
379k
source:
50 FR 7493, Feb. 22, 1985, unless otherwise noted.
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