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).
To request assistance from ORAQ, please complete the Regulatory Affairs (RA) Service Request Form. For questions or additional information, please see the RA Service Request Form FAQs and Drug/Biologic Project FAQs.
Response to Service Requests
Following the submission of a service request form, you will be contacted directly by a Regulatory Affairs Scientist who will assist with the request. ORAQ aims to provide an initial response to all service requests within two business days. For time-sensitive requests, we ask that you email our shared inbox at ORAQ@duke.edu following the submission of a service request form.
Timeline for Document Reviews
All Duke-sponsored regulatory submissions to the FDA (or other federal regulatory agency) must be reviewed and submitted by ORAQ. The timeline for review of regulatory documents will vary based on the complexity of the application and submission materials. ORAQ aims to review and provide feedback on submissions as specified:
- High Complexity- Project requires product manufacturing and nonclinical safety studies. Projects of this type would include full manufacturing information as well as multiple nonclinical safety studies on the investigational product. These submissions will be reviewed in 15-30 business days.
- Medium Complexity- Project requires some product manufacturing and/or nonclinical safety studies. Projects of this type would include limited manufacturing activities, such as fill-finish, testing of a final product, or repackaging and may include limited reports on nonclinical safety studies. These submissions will be reviewed in 10-20 business days.
- Low Complexity- Project does not require product manufacturing or nonclinical safety studies. Projects of this type would include off-label use of an approved product or use of a commercially supplied investigational product with right of reference (e.g., LOA) to an existing regulatory application. These submissions will be reviewed in 3-10 business days.
As part of the review, ORAQ may identify issues that require remediation prior to submission to FDA. The correction of identified issues may take time and could result in an additional review by ORAQ. We ask that you keep this in mind when planning an ORAQ review.