U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 21Chapter IPart 601 - PART 601—LICENSING
Subpart A [§ 601.2 - § 601.9] - Subpart A—General Provisions
Subpart B - Subpart B [Reserved]
Subpart C [§ 601.12 - § 601.29] - Subpart C—Biologics Licensing
Subpart D [§ 601.30 - § 601.35] - Subpart D—Diagnostic Radiopharmaceuticals
Subpart E [§ 601.40 - § 601.46] - Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
Subpart F [§ 601.50 - § 601.51] - Subpart F—Confidentiality of Information
Subpart G [§ 601.70 - § 601.70] - Subpart G—Postmarketing Studies
Subpart H [§ 601.90 - § 601.95] - Subpart H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
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