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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i6
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 601
    PART 601—LICENSING

Part 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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