What are the new regulatory review and submission requirements?
Duke University School of Medicine is requiring that all Duke-sponsored regulatory submissions to the U.S. Food and Drug Administration (FDA) (or other federal regulatory agency) be reviewed and submitted by the Office of Regulatory Affairs and Quality (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
In addition to reviewing and submitting all regulatory submissions, ORAQ must also receive copies of any formal correspondence (e.g., requests for information) with the FDA or other federal regulatory agency.
Why were these changes implemented?
The School of Medicine is aiming to improve the quality of regulatory submissions, reduce delays associated with regulatory approvals, and decrease risk by ensuring compliance with federal regulations.
Who is affected?
These requirements will apply to all Duke University faculty, students, medical professionals, or other Duke employees who submit a regulatory submission to the FDA or another federal regulatory agency (e.g., Health Canada). Research professionals that support regulatory submissions should be aware of the review and submission requirements and assist faculty with compliance.
When did the new requirements go into effect?
On January 1, 2022, the requirement for ORAQ review and submission of all Duke-sponsored regulatory submissions to the FDA (or other federal regulatory agency) went into effect.
I am a Regulatory Coordinator currently managing applications for a Duke faculty sponsor. Can I continue to assist with regulatory applications as long as I ensure institutional requirements are met?
Yes, ORAQ encourages research support staff to continue to assist faculty with regulatory applications. We have briefly summarized how the new institutional requirements can be applied to this model of support below:
- Initial applications and maintenance submissions can still be drafted by the study team, but all submissions need to be reviewed and submitted by ORAQ.
- Study teams can still serve as the secondary FDA contact as long as any formal FDA correspondence (i.e., requests for information, etc.) is shared with ORAQ.
Do I still need to complete an ORAQ web form to register a new regulatory application (e.g., IND, IDE, ITP) with ORAQ?
No, study teams no longer need to complete a web form on the ORAQ website to register a new application. Instead, your assigned ORAQ Regulatory Affairs Scientist will enter the application into a new REDCap database to register it with our office. The sponsor and designated contacts will receive an automated registration email from REDCap after the application has been entered in the database. Sponsors and designated contacts will also receive automated REDCap emails of reporting requirements associated with the application. These reminders will be sent in advance of all applicable reporting deadlines.
How do I request regulatory review and submission or other support from ORAQ?
To engage ORAQ in review and submission of a regulatory submission or other support, please complete the Regulatory Affairs (RA) Service Request Form. Please be sure to review the FAQs and expectations on timelines before completing the RA Service Request Form.
Who do I contact with additional questions?
Additional questions can be sent to our general inbox at ORAQ@duke.edu. Alternatively, questions can be directed to Regulatory Affairs leadership at email@example.com or firstname.lastname@example.org.