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

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 601
8. ›
9. Subpart H

Sections

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