ORAQ provides comprehensive regulatory support to Duke faculty developing or conducting research with FDA-regulated products, including investigational drugs/biologics, medical devices, and tobacco products. We offer support with regulatory strategy development, FDA meetings, and preparation and submission of all regulatory applications. To request assistance from ORAQ, please complete the Regulatory Affairs (RA) Service Request Form.
As of November 1, 2019, Duke University School of Medicine has instituted the following requirements:
- All initial IND, IDE, and ITP applications are to be reviewed by ORAQ prior to submission to the FDA.
- ORAQ must receive a final copy of all IND, IDE, and ITP submissions, including any supplements, reports, and amendments to the initial application.
- ORAQ must receive copies of any formal FDA correspondence.
Faculty sponsors and study teams can comply with these requirements by requesting a review or uploading a final copy of a regulatory submission using the RA Service Request Form. Copies of FDA correspondence can be shared directly with the Regulatory Affairs Scientist supporting your project. If you haven't been connected with a Regulatory Affairs Scientist, please submit FDA correspondence to ORAQ@duke.edu. For questions or additional information, please see our frequently asked questions on the new regulatory review requirements and use of the RA Service Request Form.
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
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 initial applications as specified:
- High Complexity- Project requires product manufacturing and nonclinical safety studies. Projects of this type would include full manufacturing information as well as a complete battery of nonclinical safety studies on the investigational product. These applications will be reviewed in 7-10 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 applications will be reviewed in 5-7 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 applications will be reviewed in 2-5 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.