Subpart I. Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

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