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U.S. Department of Health and Human Services

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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Approvals & Clearances

 

Contact FDA

(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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