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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 H - Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible |
| § 601.90 - Scope. |
| § 601.91 - Approval based on evidence of effectiveness from studies in animals. |
| § 601.92 - Withdrawal procedures. |
| § 601.93 - Postmarketing safety reporting. |
| § 601.94 - Promotional materials. |
| § 601.95 - Termination of requirements. |