Title 21

PART 314 SUBPART B

Subpart B - Applications

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

21:5.0.1.1.4.2.1.1	SECTION 314.50	314.50 Content and format of an NDA.
21:5.0.1.1.4.2.1.2	SECTION 314.52	314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
21:5.0.1.1.4.2.1.3	SECTION 314.53	314.53 Submission of patent information.
21:5.0.1.1.4.2.1.4	SECTION 314.54	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.
21:5.0.1.1.4.2.1.5	SECTION 314.55	314.55 Pediatric use information.
21:5.0.1.1.4.2.1.6	SECTION 314.60	314.60 Amendments to an unapproved NDA, supplement, or resubmission.
21:5.0.1.1.4.2.1.7	SECTION 314.65	314.65 Withdrawal by the applicant of an unapproved application.
21:5.0.1.1.4.2.1.8	SECTION 314.70	314.70 Supplements and other changes to an approved NDA.
21:5.0.1.1.4.2.1.9	SECTION 314.71	314.71 Procedures for submission of a supplement to an approved application.
21:5.0.1.1.4.2.1.10	SECTION 314.72	314.72 Change in ownership of an application.
21:5.0.1.1.4.2.1.11	SECTION 314.80	314.80 Postmarketing reporting of adverse drug experiences.
21:5.0.1.1.4.2.1.12	SECTION 314.81	314.81 Other postmarketing reports.
21:5.0.1.1.4.2.1.13	SECTION 314.90	314.90 Waivers.

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