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Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter F
Part 601
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.