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Vaccines, Blood & Biologics
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Resources for You
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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 301-443-1240
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Key Resources
- Access to Investigational Drugs
- Information on Submitting an Investigational New Drug Application
- Federal Register Notice: New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule
5/31/2002 (aka Animal Rule) - Animal Models — Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135KB)
- Clinical Investigator Information
- Participation of Females in Clinical Trials and Gender Analysis of Data in Biologic Product Applications
- References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies
- Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)
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Training
- FDA Clinical Investigator Training Course
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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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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