Part 601 — Licensing

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• Subpt. A General Provisions §§601.2 to 601.9
• Subpt. B Subpart B [Reserved]
• Subpt. C Biologics Licensing §§601.12 to 601.29
• Subpt. D Diagnostic Radiopharmaceuticals §§601.30 to 601.35
• Subpt. E Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses §§601.40 to 601.46
• Subpt. F Confidentiality of Information §§601.50 to 601.51
• Subpt. G Postmarketing Studies §601.70
• Subpt. H Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible §§601.90 to 601.95