Subpart B - APPLICATIONS
- Section 314.50 - Content and format of an NDA
- Section 314.52 - Notice of certification of invalidity, unenforceability, or noninfringement of a patent
- Section 314.53 - Submission of patent information
- Section 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
- Section 314.55 - Pediatric use information
- Section 314.60 - Amendments to an unapproved NDA, supplement, or resubmission
- Section 314.65 - Withdrawal by the applicant of an unapproved application
- Section 314.70 - Supplements and other changes to an approved NDA
- Section 314.71 - Procedures for submission of a supplement to an approved application
- Section 314.72 - Change in ownership of an application
- Section 314.80 - Postmarketing reporting of adverse drug experiences
- Section 314.81 - Other postmarketing reports
- Section 314.90 - Waivers