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U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 27, 2025
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Title 21
Chapter I
Part 314
Subpart I - 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.
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