Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Biologics
  6. Licensing
  7. Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible

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Section
601.90

Scope.

Section
601.91

Approval based on evidence of effectiveness from studies in animals.

Section
601.92

Withdrawal procedures.

Section
601.93

Postmarketing safety reporting.

Section
601.94

Promotional materials.

Section
601.95

Termination of requirements.