IND/IDE Applications
Once you determine whether you need an Investigational New Drug (IND) or Investigational Device Exemption (IDE), we can help submit the required documents to the FDA.
How we help
- Assistance with:
- Pre-IND/IDE/BLA or other pre-submission queries
- Submitting formal IND/IDE determination requests to the FDA
- Submission of an IND or IDE application
- Annual reports and safety reporting to the FDA
- Preparation for FDA inspections of investigator-sponsored clinical trials.
- Updates regarding new guidance documents, inspection trends, inspection actions, and new regulatory actions taken by FDA relating to clinical trials.
Cost
Free for University of Minnesota investigators.
Consult with an expert
Sydney Viel
Regulatory Affairs Program Manager
[email protected]
Melissa Hansen
Research Navigator
[email protected]
612-625-CTSI (2874)