Code of Federal Regulations · Subpart

Subpart H — Approval Of Biological Products When Human Efficacy Studies Are Not Ethical Or Feasible

21 C.F.R. pt. 601, subpt. H

• § 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