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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
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Content current as of:
03/25/2025
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