21 CFR Part 314 for FDA approval to market a new drug

21 CFR PART 314 —APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

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Subpart A—General Provisions

314.1   Scope of this part.

314.2   Purpose.

314.3   Definitions.

Subpart B—Applications

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.

314.60   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.

 

Subpart C—Abbreviated Applications

314.92   Drug products for which abbreviated applications may be submitted.

314.93   Petition to request a change from a listed drug.

314.94   Content and format of an ANDA.

314.95   Notice of certification of invalidity, unenforceability, or noninfringement of a patent.

314.96   Amendments to an unapproved ANDA.

314.97   Supplements and other changes to an approved ANDA.

314.98   Postmarketing reports.

314.99   Other responsibilities of an applicant of an ANDA.

 

Subpart D—FDA Action on Applications and Abbreviated Applications

314.100   Timeframes for reviewing applications and abbreviated applications.

314.101   Filing an NDA and receiving an ANDA.

314.102   Communications between FDA and applicants.

314.103   Dispute resolution.

314.104   Drugs with potential for abuse.

314.105   Approval of an NDA and an ANDA.

314.106   Foreign data.

314.107   Date of approval of a 505(b)(2) application or ANDA.

314.108   New drug product exclusivity.

314.110   Complete response letter to the applicant.

314.120   [Reserved]

314.122   Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.

314.125   Refusal to approve an NDA.

314.126   Adequate and well-controlled studies.

314.127   Refusal to approve an ANDA.

314.150   Withdrawal of approval of an application or abbreviated application.

314.151   Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.

314.152   Notice of withdrawal of approval of an application or abbreviated application for a new drug.

314.153   Suspension of approval of an abbreviated new drug application.

314.160   Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.

314.161   Determination of reasons for voluntary withdrawal of a listed drug.

314.162   Removal of a drug product from the list.

314.170   Adulteration and misbranding of an approved drug.

 

Subpart E—Hearing Procedures for New Drugs

314.200   Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.

314.201   Procedure for hearings.

314.235   Judicial review.

 

Subpart F [Reserved]

 

Subpart G—Miscellaneous Provisions

314.410   Imports and exports of new drugs.

314.420   Drug master files.

314.430   Availability for public disclosure of data and information in an application or abbreviated application.

314.440   Addresses for applications and abbreviated applications.

314.445   Guidance documents.

 

Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses

314.500   Scope.

314.510   Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

314.520   Approval with restrictions to assure safe use.

314.530   Withdrawal procedures.

314.540   Postmarketing safety reporting.

314.550   Promotional materials.

314.560   Termination of requirements.

 

Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

314.600   Scope.

314.610   Approval based on evidence of effectiveness from studies in animals.

314.620   Withdrawal procedures.

314.630   Postmarketing safety reporting.

314.640   Promotional materials.

314.650   Termination of requirements.

21 CFR Part 314 for FDA approval to market a new drug: