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Approval of New Drugs 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. Drugs for Human Use
  6. Applications for FDA Approval to Market a New Drug
  7. 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.

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