21 CFR Part 314 Guidelines for FDA Approval to Market a New Drug

21 CFR Part 314 Guidelines for FDA Approval to Market a New Drug

21 CFR Part 314 Guidelines for FDA Approval to Market a New Drug

(A). This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them. 

(B). This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.

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Table of Contents

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 Guidelines for FDA approval to market a new drug:

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