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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 F - Biologics |
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Part 601 - Licensing |
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Subpart E - Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses |
| § 601.40 - Scope. |
| § 601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. |
| § 601.42 - Approval with restrictions to assure safe use. |
| § 601.43 - Withdrawal procedures. |
| § 601.44 - Postmarketing safety reporting. |
| § 601.45 - Promotional materials. |
| § 601.46 - Termination of requirements. |