Our goal is to provide the Duke community with the tools, training and support needed to navigate the complex regulatory pathways that accompany translational research. We aim to do this by providing support in the following areas:

• Early Regulatory Strategy Development: We encourage early interaction as a means to develop a regulatory strategy that is appropriate for the complexity of your research project.
• Preclinical Testing and GMP Manufacturing: We provide guidance and support to research teams developing and executing preclinical studies or manufacturing investigational products.
• Regulatory Submissions and Maintenance: We provide full preparation, submission, and maintenance of regulatory applications to the FDA.  See template documents.
• FDA Meetings: We can prepare, schedule, and facilitate meetings with the FDA for feedback on investigational product development plans.
• FDA Inspections: We host FDA audits/inspections of the Duke GMP manufacturing facilities and can assist with the preparation and implementation of responses to audit observations for these facilities. In collaboration with OARC, we also assist with inspections of clinical studies and product manufacturing under Duke-sponsored regulatory applications.
• Educational Opportunities: We provide a variety of education and training, including the Regulatory Affairs Training Program and Sponsor and Investigator Training.
• Outreach and Collaboration: We are a contributing member of ReGARDD, a regional regulatory forum that offers guidance to academic researchers through curation of resources at ReGARDD.org. 

Questions? Contact our “help desk” at ORAQ@duke.edu.

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. All Duke-sponsored regulatory submissions to the FDA (or other federal regulatory agency) must be reviewed and submitted by ORAQ.   

                             Learn about Duke Regulatory Support! 

Want to know more about FDA regulation of medical products? Click on the image below to take a short course.

Physicians interested in using an investigational drug (i.e., not FDA approved) to treat a patient with a serious or immediately life-threatening condition can now receive full support in obtaining regulatory authorizations and throughout the entire process. Use of an investigational drug outside of a clinical trial requires a physician to obtain informed consent and seek authorization from the drug company, the Food and Drug Administration (FDA), and the Institutional Review Board (IRB). To utilize the Individual Patient IND Support resource, please complete the survey of required information and key staff will be notified of your request. If you would like additional information, please visit Individual Patient IND Support or contact ORAQ@duke.edu. 

                                         Individual Patient IND Request Survey

The Office of Regulatory Affairs and Quality (ORAQ) is supported in part by Duke’s Clinical and Translational Science Award (CTSA) from the National Center for Advancing Translational Sciences (NCATS). Please cite the CTSA grant (UL1TR002553​) in publications utilizing ORAQ resources and register your publication with PubMed Central.

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