Regulatory Services Available from the HRPP

Appendix

Governing Policy

These IND/IDE services are intended to promote compliance with Food and Drug Administration (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 Institutional Review Board (IRB). 

The following services are available upon request:

  • Offer explanation of IND and IDE regulations
  • Assist with requesting “not significant risk” (NSR) determinations
  • Assist in understanding the obligations of a sponsor or 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 an IND or IDE
  • Assist in submitting pre-IND/IDE,  IND and IDE applications to the FDA
  • Assist in scheduling, coordinating, preparing and attending meetings with the 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 HRPP at 612-626-5654 or email at [email protected]

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