Federal (United States) · Regulations
Part 601 — LICENSING
39 sections
7 groups
- Subpart A — General Provisions8 sections
- Subpart C — Biologics Licensing9 sections
- Subpart D — Diagnostic Radiopharmaceuticals6 sections
- Subpart E — Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses7 sections
- Subpart F — Confidentiality of Information2 sections
- Subpart G — Postmarketing Studies1 section
- Subpart H — Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible6 sections