21 CFR Subpart H
Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
June 25, 2020
§
601.91
Approval based on evidence of effectiveness from studies in animals
§
601.92
Withdrawal procedures
§
601.93
Postmarketing safety reporting
§
601.90
Scope
§
601.94
Promotional materials
§
601.95
Termination of requirements
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