IND/IDE determination and support
CTSI's Regulatory Support function, in collaboration with the University of Minnesota's Human Research Protection Program (HRPP) IND/IDE function, assist investigators initiating a study that involves an investigational agent in human research participants with the determination and necessary attainment of an investigational new drug (IND) or investigational device exemption (IDE) from the Food and Drug Administration (FDA).
- Assistance determining whether a protocol requires an IND or IDE
- Assistance assembling the FDA application for an IND or IDE and submission of the application
FDA meeting support
- Preparation and support for FDA meeting requests
- Expert guidance navigating the regulations
Associated fees and funding for services
There are no fees for the investigator, study team, or department for IND/IDE determination and application support.
Contact us to coordinate access to office hours:
- HRPP IND/IDE: By appointment only
- CTSI IND/IDE Assistance Program: Available during regular business hours