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Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Drugs for Human Use
Applications for FDA Approval to Market a New Drug
Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
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Section
314.600
Scope.
Section
314.610
Approval based on evidence of effectiveness from studies in animals.
Section
314.620
Withdrawal procedures.
Section
314.630
Postmarketing safety reporting.
Section
314.640
Promotional materials.
Section
314.650
Termination of requirements.