21 CFR Part 314 - 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.