Frequently Asked Questions

Which FDA office may an IRB contact to determine whether an investigational new drug application (IND) or investigational device exemption (IDE) is required for a study of a test article?

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Clinical: Biopharma
  • Drugs: contact the Center for Drug Evaluation and Research (CDER), Office of Communications, Division of Drug Information at (301) 796-3400
  • Biological Products: contact the Center for Biologics Evaluation and Research (CBER), Office of Communication, Outreach and Development, at (800)-835-4709 or (301) 827-1800.
  • Medical Devices: contact the Investigational Device Exemption (IDE) Staff, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), at (301) 796-5640.