SUBPART H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible (§601.90 to §601.95)
- 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.