Code of Federal Regulations · Subpart

Subpart B — Applications

21 C.F.R. pt. 314, subpt. B

• § 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