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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 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. |