Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible | Midpage

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Code of Federal Regulations

Subpart I

Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

314.600Scope.314.610Approval based on evidence of effectiveness from studies in animals.314.620Withdrawal procedures.314.630Postmarketing safety reporting.314.640Promotional materials.314.650Termination of requirements.