Part 601 - LICENSING
- Subpart A - GENERAL PROVISIONS (§§ 601.2 — 601.9)
- 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)