![]() |
Code of Federal Regulations (Last Updated: July 5, 2024) |
![]() |
Title 21 - Food and Drugs |
![]() |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
![]() |
SubChapter F - Biologics |
![]() |
Part 601 - Licensing |
![]() |
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. |