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Vaccines, Blood & Biologics

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Licensed Products (BLAs)

The following products are regulated as Biologics License Applications (BLAs):  

  • Fractionated Plasma Products (Alpha-1-Proteinase Inhibitor, Antihemophilic Factor, Antithrombin, C1 Esterase Inhibitor, Coagulation Factors, Fibrin, Fibrinogen, Immune Globulins, Protein C, Thrombin)
  • Blood Donor Screening Tests for Infectious Diseases
  • Blood Grouping and Phenotyping Reagents

 

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Licensed Blood Products With Supporting Documents

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Approvals & Clearances

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Contact Us

  • (800) 835-4709
  • (301) 827-1800

  • Consumer Affairs Branch (CBER)

    Division of Communication and Consumer Affairs

    Office of Communication, Outreach and Development

    Food and Drug Administration

    1401 Rockville Pike

    Suite 200N/HFM-47

    Rockville, MD 20852-1448

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