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?
For drugs, the IRB may contact the Drug Information Branch, Center for Drug Evaluation and Research (CDER), at (301) 827-4573. For a biological blood product, contact the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), at 301-827-3518. For a biological vaccine product, contact the Office of Vaccines Research and Review at 301-827-0648. For a biological Therapeutic product, contact the Office of Therapeutics Research and Review, CBER, at 301-594-2860. For a medical device, contact the Program Operation Staff, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), at (301) 594-1190. If the IRB is unsure about whether a test article is a “drug,” a “biologic” or a “device,” the IRB may contact the Health Assessment Policy Staff, Office of Health Affairs, at (301) 827-1685.
Related 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?
- How can I determine if an Investigational New Drug Application (IND) is required for my study?
- Where should I send my Investigational New Drug application (IND) submission?
