SUBPART I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible (§314.600 to §314.650)
- 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.