---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchF/part601"
level: "part"
label: "Part 601"
heading: "Licensing"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchF-part601"
sections_count: 39
---

# Part 601 — Licensing

Title 21 C.F.R. — Food and Drugs › Chapter I — Food and Drug Administration, Department of Health and Human Services › Subchapter F — Biologics

## Contents

- [Subpart A — General Provisions](/cfr/21/chI-subchF-part601-subpartA.md)
- [Subpart B — Subpart B [Reserved]](/cfr/21/chI-subchF-part601-subpartB.md)
- [Subpart C — Biologics Licensing](/cfr/21/chI-subchF-part601-subpartC.md)
- [Subpart D — Diagnostic Radiopharmaceuticals](/cfr/21/chI-subchF-part601-subpartD.md)
- [Subpart E — Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses](/cfr/21/chI-subchF-part601-subpartE.md)
- [Subpart F — Confidentiality of Information](/cfr/21/chI-subchF-part601-subpartF.md)
- [Subpart G — Postmarketing Studies](/cfr/21/chI-subchF-part601-subpartG.md)
- [Subpart H — Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible](/cfr/21/chI-subchF-part601-subpartH.md)