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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 314 - Applications for FDA Approval to Market a New Drug |
| 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. |
| § 314.91 - Obtaining a reduction in the discontinuance notification period. |
| 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 - XXX |
| § 314.300 - Procedure for the issuance, amendment, or repeal of regulations. |
| 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. |