APPENDIX TO POLICY
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 firstname.lastname@example.org.