Code of Federal Regulations · Part

Part 601 — Licensing

21 C.F.R. pt. 601

• Subpart A General Provisions
• Subpart B Subpart B [reserved]
• Subpart C Biologics Licensing
• Subpart D Diagnostic Radiopharmaceuticals
• Subpart E Accelerated Approval Of Biological Products For Serious Or Life-threatening Illnesses
• Subpart F Confidentiality Of Information
• Subpart G Postmarketing Studies
• Subpart H Approval Of Biological Products When Human Efficacy Studies Are Not Ethical Or Feasible