Once you’ve compiled the required documents for your initial Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission, they can be submitted with the help of the Clinical and Translational Science Institute’s regulatory team, or, for oncology studies, with the help of the Masonic Cancer Center’s Clinical Trials Office (CTO) team.
How long reviews take
The FDA has 30 calendar days to review an initial IND or IDE application. At the end of 30 calendar days, the FDA reviewers must provide either:
A "Study May Proceed" letter indicating that the application is approved, in which case the study may begin recruiting (with IRB approval).
A request for information or modification, in which case study activities may not proceed until FDA requests have been resolved.
FDA reviewers often reach out before the end of the 30-day review window to ask for clarifying information or to issue a full clinical hold; this ends the 30-day clock and you must wait for approval to proceed. The interactive review process may mean multiple rounds of submissions to answer reviewer questions and requests.
Approval
Approval is usually communicated first by email and then a formal approval letter is mailed to the sponsor-investigator. This letter indicates “Study May Proceed” or “Safe to Proceed” (or similar wording) and is dated with the approval date. All communications will be sent from FDA using the contact information provided in the application.
Once you receive the Study May Proceed letter and you have IRB approval, you can proceed with your clinical activities. Be sure to submit all submissions and FDA responses to the UMN Central File.
If you have not heard from the FDA after 30 calendar days, we strongly recommend reaching out to your assigned FDA reviewer to confirm your application was approved before you proceed.
