Subpart H. Subpart H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible

• § 601.90 - Scope.
• § 601.91 - Approval based on evidence of effectiveness from studies in animals.
• § 601.92 - Withdrawal procedures.
• § 601.93 - Postmarketing safety reporting.
• § 601.94 - Promotional materials.
• § 601.95 - Termination of requirements.