Title 21, Part 314 — Applications for Fda Approval to Market a New Drug
69 sections
Section 314.1
Scope of this part.
Section 314.2
Purpose.
Section 314.3
Definitions.
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 314.56
Nonprescription drug product with an additional condition for nonprescription use (ACNU).
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.
Section 314.92
Drug products for which abbreviated applications may be submitted.
Section 314.93
Petition to request a change from a listed drug.
Section 314.94
Content and format of an ANDA.
Section 314.95
Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
Section 314.96
Amendments to an unapproved ANDA.
Section 314.97
Supplements and other changes to an approved ANDA.
Section 314.98
Postmarketing reports.
Section 314.99
Other responsibilities of an applicant of an ANDA.
Section 314.100
Timeframes for reviewing applications and abbreviated applications.
Section 314.101
Filing an NDA and receiving an ANDA.
Section 314.102
Communications between FDA and applicants.
Section 314.103
Dispute resolution.
Section 314.104
Drugs with potential for abuse.
Section 314.105
Approval of an NDA and an ANDA.
Section 314.106
Foreign data.
Section 314.107
Date of approval of a 505(b)(2) application or ANDA.
Section 314.108
New drug product exclusivity.
Section 314.110
Complete response letter to the applicant.
Section 314.120
[Reserved]
Section 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.
Section 314.125
Refusal to approve an NDA.
Section 314.126
Adequate and well-controlled studies.
Section 314.127
Refusal to approve an ANDA.
Section 314.150
Withdrawal of approval of an application or abbreviated application.
Section 314.151
Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
Section 314.152
Notice of withdrawal of approval of an application or abbreviated application for a new drug.
Section 314.153
Suspension of approval of an abbreviated new drug application.
Section 314.160
Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
Section 314.161
Determination of reasons for voluntary withdrawal of a listed drug.
Section 314.162
Removal of a drug product from the list.
Section 314.170
Adulteration and misbranding of an approved drug.
Section 314.200
Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
Section 314.201
Procedure for hearings.
Section 314.235
Judicial review.
Section 314.410
Imports and exports of new drugs.
Section 314.420
Drug master files.
Section 314.430
Availability for public disclosure of data and information in an application or abbreviated application.
Section 314.440
Addresses for applications and abbreviated applications.
Section 314.445
Guidance documents.
Section 314.500
Scope.
Section 314.510
Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
Section 314.520
Approval with restrictions to assure safe use.
Section 314.530
Withdrawal procedures.
Section 314.540
Postmarketing safety reporting.
Section 314.550
Promotional materials.
Section 314.560
Termination of requirements.
Section 314.600
Scope.
Section 314.610
Approval based on evidence of effectiveness from studies in animals.
Section 314.620
Withdrawal procedures.
Section 314.630
Postmarketing safety reporting.
Section 314.640
Promotional materials.
Section 314.650
Termination of requirements.