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
- § 314.60 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