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Code of Federal Regulations (Last Updated: October 10, 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 I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible |
| § 314.600 - Scope. |
| § 314.610 - Approval based on evidence of effectiveness from studies in animals. |
| § 314.620 - Withdrawal procedures. |
| § 314.630 - Postmarketing safety reporting. |
| § 314.640 - Promotional materials. |
| § 314.650 - Termination of requirements. |