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Code of Federal Regulations (Last Updated: November 8, 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 |
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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- Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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. |