Being able to perform (Food and Drug Administration) FDA approved studies for the new drugs and devices brings ideas from MU SOM researchers to reality in clinical trials, serving patients.
Researchers at the MU SOM have exceptional, experienced resources to successfully navigate the regulatory landscape to gain approvals for new drugs and medical devices, including Investigational New Drug (IND) and Investigational Device Exemption (IDE) clinical trials.
Regulatory affairs support includes:
- Determine if a new drug or device will require an FDA approved clinical study
- Determine if an FDA approval will be required to study a “new use” for a drug or device
- FDA submission development for Investigator Initiated / Investigator Sponsored trials
- Serve as FDA Authorized Representative / Official Correspondent for IND / IDE
- Submit IDE / IND. Help develop:
- Study protocol
- Patient consent draft
- Case report forms (CRFs)
- Instructions for Use (IFU) / Investigator’s Brochure
- Device / drug description
- Bench, animal, human testing
- Investigator agreement, financial disclosure
- Support through time sensitive FDA review processes
- Submission of Progress, Annual, and Final Reports to FDA; help with:
- Report development
- Data analyses
- ClinicalTrials.gov postings
- Submit IDE / IND. Help develop:
- Records retention
- Permit and always be prepared for FDA inspections
- Serve as FDA Authorized Representative / Official Correspondent for IND / IDE
