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).
Determination assistance
- Assistance determining whether a protocol requires an IND or IDE
Application assistance
- 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
Regulation guidance
- 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.
Office hours
Contact us to coordinate access to office hours:
- HRPP IND/IDE: By appointment only
- CTSI IND/IDE Assistance Program: Available during regular business hours
Contact
[email protected]
612-625-4000