SUBPART B—Applications (§314.50 to §314.91)
- 314.50—Content and format of an application.
- 314.52—Notice of certification of invalidity or noninfringement of a patent.
- 314.53—Submission of patent information.
- 314.54—Procedure for submission of an 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 application, supplement, or resubmission.
- 314.65—Withdrawal by the applicant of an unapproved application.
- 314.70—Supplements and other changes to an approved application.
- 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.
- 314.91—Obtaining a reduction in the discontinuance notification period.