Regulatory support and assistance in navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications is available through the UNC Clinical Research Compliance Office (CRCO). For assistance regarding IND/IDE submissions to the FDA, contact the Clinical Research Compliance Office at This email address is being protected from spambots. You need JavaScript enabled to view it..
The CRCO provides support to UNC researchers in the preparation or review of:
- Initial IND or IDE applications
- Annual progress reports
- Responses to FDA inquiries
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
ReGARDD.org: A website focused on providing academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics, and medical devices. Contains current best practices for preparing IND and IDE submissions to the FDA. Includes up-to-date federal regulations, protocol and submission templates, and in-depth guidance concerning drug and device clinical research pathways. Hosted and maintained by ReGARDD affiliates at UNC, Duke, Wake Forest, MUSC, and RTI International.
Workshops
Investigational New Drug (IND) Workshop
September 25, 2017
PART 1: IND Exemption Studies and Pre-IND Meetings (Kristen Foss, PhD, RAC, Regulatory Affairs Scientist)
PART 2: IND Preparation and Maintenance (Stephanie Pierce, PhD, Regulatory Affairs Scientist)
view slides
November 20, 2018
PART 1: IND Exemption Studies and Pre-IND Meetings (Daniel Tonkin, PhD, RAC, Regulatory Affairs Scientist)
PART 2: IND Preparation and Maintenance (Kristen Foss, PhD, RAC, Regulatory Affairs Scientist)
view slides
Investigational Device Exemption (IDE) Workshop
September 26, 2017
PART 1: Medical Device Studies and the IDE (Kelly Lindblom, PhD Regulatory Affairs Scientist)
PART 2: IDE Best Practices and Additional Studies (Sarah Gemberling, PhD, RAC Regulatory Affairs Scientist)
view slides
November 8, 2018
PART 1: Medical Device Studies and the IDE (Kelly Lindblom, PhD, Regulatory Affairs Scientist)
PART 2: IDE Best Practices and Additional Studies (Stephanie Pierce, PhD, Regulatory Affairs Scientist)
view slides
