| 21:5.0.1.1.4.1 | SUBPART A
| Subpart A - General Provisions | |
| 21:5.0.1.1.4.1.1.1 | SECTION 314.1
| 314.1 Scope of this part. | |
| 21:5.0.1.1.4.1.1.2 | SECTION 314.2
| 314.2 Purpose. | |
| 21:5.0.1.1.4.1.1.3 | SECTION 314.3
| 314.3 Definitions. | |
| 21:5.0.1.1.4.2 | SUBPART B
| Subpart B - Applications | |
| 21:5.0.1.1.4.2.1.1 | SECTION 314.50
| 314.50 Content and format of an NDA. | |
| 21:5.0.1.1.4.2.1.2 | SECTION 314.52
| 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent. | |
| 21:5.0.1.1.4.2.1.3 | SECTION 314.53
| 314.53 Submission of patent information. | |
| 21:5.0.1.1.4.2.1.4 | SECTION 314.54
| 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. | |
| 21:5.0.1.1.4.2.1.5 | SECTION 314.55
| 314.55 Pediatric use information. | |
| 21:5.0.1.1.4.2.1.6 | SECTION 314.60
| 314.60 Amendments to an unapproved NDA, supplement, or resubmission. | |
| 21:5.0.1.1.4.2.1.7 | SECTION 314.65
| 314.65 Withdrawal by the applicant of an unapproved application. | |
| 21:5.0.1.1.4.2.1.8 | SECTION 314.70
| 314.70 Supplements and other changes to an approved NDA. | |
| 21:5.0.1.1.4.2.1.9 | SECTION 314.71
| 314.71 Procedures for submission of a supplement to an approved application. | |
| 21:5.0.1.1.4.2.1.10 | SECTION 314.72
| 314.72 Change in ownership of an application. | |
| 21:5.0.1.1.4.2.1.11 | SECTION 314.80
| 314.80 Postmarketing reporting of adverse drug experiences. | |
| 21:5.0.1.1.4.2.1.12 | SECTION 314.81
| 314.81 Other postmarketing reports. | |
| 21:5.0.1.1.4.2.1.13 | SECTION 314.90
| 314.90 Waivers. | |
| 21:5.0.1.1.4.3 | SUBPART C
| Subpart C - Abbreviated Applications | |
| 21:5.0.1.1.4.3.1.1 | SECTION 314.92
| 314.92 Drug products for which abbreviated applications may be submitted. | |
| 21:5.0.1.1.4.3.1.2 | SECTION 314.93
| 314.93 Petition to request a change from a listed drug. | |
| 21:5.0.1.1.4.3.1.3 | SECTION 314.94
| 314.94 Content and format of an ANDA. | |
| 21:5.0.1.1.4.3.1.4 | SECTION 314.95
| 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent. | |
| 21:5.0.1.1.4.3.1.5 | SECTION 314.96
| 314.96 Amendments to an unapproved ANDA. | |
| 21:5.0.1.1.4.3.1.6 | SECTION 314.97
| 314.97 Supplements and other changes to an approved ANDA. | |
| 21:5.0.1.1.4.3.1.7 | SECTION 314.98
| 314.98 Postmarketing reports. | |
| 21:5.0.1.1.4.3.1.8 | SECTION 314.99
| 314.99 Other responsibilities of an applicant of an ANDA. | |
| 21:5.0.1.1.4.4 | SUBPART D
| Subpart D - FDA Action on Applications and Abbreviated Applications | |
| 21:5.0.1.1.4.4.1.1 | SECTION 314.100
| 314.100 Timeframes for reviewing applications and abbreviated applications. | |
| 21:5.0.1.1.4.4.1.2 | SECTION 314.101
| 314.101 Filing an NDA and receiving an ANDA. | |
| 21:5.0.1.1.4.4.1.3 | SECTION 314.102
| 314.102 Communications between FDA and applicants. | |
| 21:5.0.1.1.4.4.1.4 | SECTION 314.103
| 314.103 Dispute resolution. | |
| 21:5.0.1.1.4.4.1.5 | SECTION 314.104
| 314.104 Drugs with potential for abuse. | |
| 21:5.0.1.1.4.4.1.6 | SECTION 314.105
| 314.105 Approval of an NDA and an ANDA. | |
| 21:5.0.1.1.4.4.1.7 | SECTION 314.106
| 314.106 Foreign data. | |
| 21:5.0.1.1.4.4.1.8 | SECTION 314.107
| 314.107 Date of approval of a 505(b)(2) application or ANDA. | |
| 21:5.0.1.1.4.4.1.9 | SECTION 314.108
| 314.108 New drug product exclusivity. | |
| 21:5.0.1.1.4.4.1.10 | SECTION 314.110
| 314.110 Complete response letter to the applicant. | |
| 21:5.0.1.1.4.4.1.11 | SECTION 314.120
| 314.120 [Reserved] | |
| 21:5.0.1.1.4.4.1.12 | SECTION 314.122
| 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. | |
| 21:5.0.1.1.4.4.1.13 | SECTION 314.125
| 314.125 Refusal to approve an NDA. | |
| 21:5.0.1.1.4.4.1.14 | SECTION 314.126
| 314.126 Adequate and well-controlled studies. | |
| 21:5.0.1.1.4.4.1.15 | SECTION 314.127
| 314.127 Refusal to approve an ANDA. | |
| 21:5.0.1.1.4.4.1.16 | SECTION 314.150
| 314.150 Withdrawal of approval of an application or abbreviated application. | |
| 21:5.0.1.1.4.4.1.17 | SECTION 314.151
| 314.151 Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act. | |
| 21:5.0.1.1.4.4.1.18 | SECTION 314.152
| 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug. | |
| 21:5.0.1.1.4.4.1.19 | SECTION 314.153
| 314.153 Suspension of approval of an abbreviated new drug application. | |
| 21:5.0.1.1.4.4.1.20 | SECTION 314.160
| 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn. | |
| 21:5.0.1.1.4.4.1.21 | SECTION 314.161
| 314.161 Determination of reasons for voluntary withdrawal of a listed drug. | |
| 21:5.0.1.1.4.4.1.22 | SECTION 314.162
| 314.162 Removal of a drug product from the list. | |
| 21:5.0.1.1.4.4.1.23 | SECTION 314.170
| 314.170 Adulteration and misbranding of an approved drug. | |
| 21:5.0.1.1.4.5 | SUBPART E
| Subpart E - Hearing Procedures for New Drugs | |
| 21:5.0.1.1.4.5.1.1 | SECTION 314.200
| 314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing. | |
| 21:5.0.1.1.4.5.1.2 | SECTION 314.201
| 314.201 Procedure for hearings. | |
| 21:5.0.1.1.4.5.1.3 | SECTION 314.235
| 314.235 Judicial review. | |
| 21:5.0.1.1.4.6 | SUBPART F
| Subpart F [Reserved] | |
| 21:5.0.1.1.4.7 | SUBPART G
| Subpart G - Miscellaneous Provisions | |
| 21:5.0.1.1.4.7.1.1 | SECTION 314.410
| 314.410 Imports and exports of new drugs. | |
| 21:5.0.1.1.4.7.1.2 | SECTION 314.420
| 314.420 Drug master files. | |
| 21:5.0.1.1.4.7.1.3 | SECTION 314.430
| 314.430 Availability for public disclosure of data and information in an application or abbreviated application. | |
| 21:5.0.1.1.4.7.1.4 | SECTION 314.440
| 314.440 Addresses for applications and abbreviated applications. | |
| 21:5.0.1.1.4.7.1.5 | SECTION 314.445
| 314.445 Guidance documents. | |
| 21:5.0.1.1.4.8 | SUBPART H
| Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses | |
| 21:5.0.1.1.4.8.1.1 | SECTION 314.500
| 314.500 Scope. | |
| 21:5.0.1.1.4.8.1.2 | SECTION 314.510
| 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. | |
| 21:5.0.1.1.4.8.1.3 | SECTION 314.520
| 314.520 Approval with restrictions to assure safe use. | |
| 21:5.0.1.1.4.8.1.4 | SECTION 314.530
| 314.530 Withdrawal procedures. | |
| 21:5.0.1.1.4.8.1.5 | SECTION 314.540
| 314.540 Postmarketing safety reporting. | |
| 21:5.0.1.1.4.8.1.6 | SECTION 314.550
| 314.550 Promotional materials. | |
| 21:5.0.1.1.4.8.1.7 | SECTION 314.560
| 314.560 Termination of requirements. | |
| 21:5.0.1.1.4.9 | SUBPART I
| Subpart I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible | |
| 21:5.0.1.1.4.9.1.1 | SECTION 314.600
| 314.600 Scope. | |
| 21:5.0.1.1.4.9.1.2 | SECTION 314.610
| 314.610 Approval based on evidence of effectiveness from studies in animals. | |
| 21:5.0.1.1.4.9.1.3 | SECTION 314.620
| 314.620 Withdrawal procedures. | |
| 21:5.0.1.1.4.9.1.4 | SECTION 314.630
| 314.630 Postmarketing safety reporting. | |
| 21:5.0.1.1.4.9.1.5 | SECTION 314.640
| 314.640 Promotional materials. | |
| 21:5.0.1.1.4.9.1.6 | SECTION 314.650
| 314.650 Termination of requirements. | |