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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 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. |