This policy describes the requirement that UW–Madison personnel register their investigator-held investigational new drug (IND) or investigational device exemption (IDE) with the UW–Madison Food and Drug Administration (FDA) Regulated Research Oversight Program.
The UW–Madison FDA-Regulated Research Oversight Program maintains a registry of all UW–Madison investigator-held INDs/IDEs to ensure institutional compliance with FDA requirements and assist investigators in fulfilling their FDA obligations.
UW–Madison personnel must initiate the IND/IDE registration process with the program no later than the time of submission to the FDA. Further guidance on the UW–Madison IND/IDE registration process is available here.
UW–Madison personnel must also notify the program when an IND/IDE has been closed, terminated, or withdrawn.