Code of Federal Regulations > Title 21 > Chapter I > Part 314 > Subpart B - Subpart B—Applications

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

§ 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 - Nonprescription drug product with an additional condition for nonprescription use (ACNU).

§ 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.