Investigational New Drug Application (IND) Information

The number of U of R Researchers who are opening their own Investigator-Sponsor INDs is increasing. It is important for these individuals to fully understand that they assume the regulatory responsibilities of the sponsor in addition to the responsibilities of being the investigator.

The following resources can aid the Investigator-Sponsor in meeting their regulatory responsibilities.

Guidance Documents:

1. Investigational New Drug (IND) Application Process
2. "Protecting Study Volunteers in Research" Chapter 5, FDA Regulated Research

FDA Contacts:

FDA Info Sheets - FAQ #56

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.

* Although this question is addressed to the IRB, the agency welcomes questions regarding INDs from Investigators.