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