Services Available from the IND/IDE Regulatory Director

The primary purpose of the IND/IDE services is to promote compliance with FDA regulations in sponsor-investigator drug, device and biologics studies at the University of Minnesota.  Sponsor-Investigators can receive guidance on pre-submission FDA interactions, IND and IDE submissions and associated reports to the FDA and the IRB. 

The following services are available upon request:

• Offer explanation of IND and IDE regulations

• Assist in understanding the obligations of a sponsor-investigator

• Assist in determining product classification, i.e., drug, device, biologic

• Assist in determining applicability of an IND or IDE

• Assist in determining contents of IND or IDE

• Assist in submitting pre-IND/IDE,  IND and IDE applications to FDA

• Assist in scheduling, coordinating, preparing and attending meetings with FDA

• Offer regulatory support for IRB applications

• Offer regulatory assistance during FDA inspections of investigator sponsored clinical trials

• Circulate periodic news items from FDA relating to sponsor-investigator clinical trials

To receive any of these services contact the IND/IDE Regulatory Director at 612-626 5654 or email the director at medreq@umn.edu.