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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Investigational New Drug (IND) or Device Exemption (IDE) Process (CBER)

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.

Emergency Use IND Requests
  • For investigational biological products regulated by CBER, call 301-827-2000
  • For all other investigational drugs, call 301-827-4570
  • After working hours, call FDA's Office of Emergency Operations at 301-796-8240
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Training

  • FDA Clinical Investigator Training CourseSee Disclaimer page regarding links to external sites Co-sponsored by FDA's Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI), with support from the National Institutes of Health
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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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