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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 601
Subpart H - 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.
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