Applications

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Applications for FDA Approval to Market a New Drug
  7. Applications

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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.