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  1. Resources for You (Biologics)

Healthcare Providers (Biologics)

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Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. The Center for Biologics Evaluation and Research (CBER) is responsible for ensuring the safety and efficacy of the biological products.

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application. In rare instances a physician may request an Emergency Use IND for a patient. Contact information for Emergency Use IND Requests:

  • For investigational biological products regulated by CBER, call 240-402-7800
  • For all other investigational drugs, call 301-796-3400 or 1-855-543-3784
  • After working hours, call FDA's Office of Emergency Operations at 301-796-8240

Blood & Blood Products

Tissue & Tissue Products

Vaccines

Xenotransplantation

Guidance, Compliance & Regulatory Information

Safety & Availability

Cell and Gene Therapy Products

Resources for You
Recalls & Alerts
Approvals & Clearances
More Information

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Contact Point
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

(800) 835-4709
(240) 402-8010

Hours Available

Food and Drug Administration
Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave
Silver Spring, MD 20993
United States


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The latest information from the Center for Biologics Evaluation and Research.


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