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U.S. Code Regulations Constitution Journal Apps
  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
  5. subpart C
    Subpart C—Biologics Licensing

Subpart C. Subpart C—Biologics Licensing

  • § 601.12 - Changes to an approved application.
  • § 601.14 - Regulatory submissions in electronic format.
  • § 601.15 - Foreign establishments and products: samples for each importation.
  • § 601.20 - Biologics licenses; issuance and conditions.
  • § 601.21 - Products under development.
  • § 601.22 - Products in short supply; initial manufacturing at other than licensed location.
  • § 601.27 - Pediatric studies.
  • § 601.28 - Annual reports of postmarketing pediatric studies.
  • § 601.29 - Guidance documents.
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