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Code of Federal Regulations

Subpart B

Applications

314.50Content and format of an NDA.314.52Notice of certification of invalidity, unenforceability, or noninfringement of a patent.314.53Submission of patent information.314.54Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.314.55Pediatric use information.314.56Nonprescription drug product with an additional condition for nonprescription use (ACNU).314.60Amendments to an unapproved NDA, supplement, or resubmission.314.65Withdrawal by the applicant of an unapproved application.314.70Supplements and other changes to an approved NDA.314.71Procedures for submission of a supplement to an approved application.314.72Change in ownership of an application.314.80Postmarketing reporting of adverse drug experiences.314.81Other postmarketing reports.314.90Waivers.