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Electronic Code of Federal Regulations

e-CFR data is current as of February 18, 2020

Title 21Chapter ISubchapter DPart 314


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER D—DRUGS FOR HUMAN USE

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

rule

Subpart A—GENERAL PROVISIONS

§314.1
Scope of this part.
§314.2
Purpose.
§314.3
Definitions.
rule

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.
rule

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.
rule

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.
rule

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.
rule

Subpart F—[RESERVED]

rule

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.
rule

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.
rule

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.

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