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Regulations last checked for updates: May 23, 2025
Title 21 - Food and Drugs last revised: May 19, 2025
All Titles
Title 21
Chapter I
Part 314
Subpart B - Subpart B—Applications
§ 314.50 - Content and format of an NDA.
§ 314.52 - Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
§ 314.53 - Submission of patent information.
§ 314.54 - Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.
§ 314.55 - Pediatric use information.
§ 314.56 - xxx
§ 314.60 - Amendments to an unapproved NDA, supplement, or resubmission.
§ 314.65 - Withdrawal by the applicant of an unapproved application.
§ 314.70 - Supplements and other changes to an approved NDA.
§ 314.71 - Procedures for submission of a supplement to an approved application.
§ 314.72 - Change in ownership of an application.
§ 314.80 - Postmarketing reporting of adverse drug experiences.
§ 314.81 - Other postmarketing reports.
§ 314.90 - Waivers.
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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