PART 601 - LICENSING
- Subpart A - General Provisions (§§ 601.2 — 601.9)
- Subpart B [Reserved]
- Subpart C - Biologics Licensing (§§ 601.12 — 601.29)
- Subpart D - Diagnostic Radiopharmaceuticals (§§ 601.30 — 601.35)
- Subpart E - Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses (§§ 601.40 — 601.46)
- Subpart F - Confidentiality of Information (§§ 601.50 — 601.51)
- Subpart G - Postmarketing Studies (§ 601.70)
- Subpart H - Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible (§§ 601.90 — 601.95)