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.
Free for University of Minnesota investigators.