On January 1, 2022, ORAQ implemented changes to regulatory support at Duke University. These changes, which have been implemented at the request of the School of Medicine, aim to improve the quality of regulatory submissions, increase efficiency and reduce delays with regulatory approvals, and decrease risk by ensuring compliance with federal regulations:
All Duke-sponsored regulatory submissions to the FDA (or other federal regulatory agency) must be reviewed and submitted by ORAQ. This includes:
- FDA meeting requests
- Initial applications and maintenance submissions associated with a clinical trial (e.g. INDs, IDEs, ITPs, CTAs)
- IND Exemption Requests
- Device Study Risk Determinations
- Master file submissions
- Marketing application submissions
- Expedited program and product designation requests (e.g. Breakthrough Therapy Designation, Orphan Drug Designation, Request for Designation, etc.)
- Export requests
- Any other regulatory submission to a federal regulatory agency
ORAQ must also receive copies of any formal correspondence with the FDA (or other federal regulatory agency).
Faculty sponsors and study teams can comply with these requirements by requesting assistance for new projects using the RA Service Request Form. Copies of FDA correspondence can be shared directly with the Regulatory Affairs Scientist supporting your project. For questions or additional information, please see our frequently asked questions on the new regulatory review and submission requirements and use of the RA Service Request Form.
If you can’t find the answers to your questions there, please reach out to us at ORAQ@duke.edu.