Subpart B—Applications

1. CFR
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3. Title 21
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5. Chapter I
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7. Part 314
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9. Subpart B

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

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