We provide full-service regulatory support and assistance in navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
Services include:
- Providing a centralized resource of information and support related to addressing regulatory requirements, obligations, and responsibilities that govern the conduct of clinical research studies under investigator-sponsored INDs and IDEs
- Assisting UNC researchers in the preparation or review of initial IND or IDE applications, annual progress reports, and preparing responses to the FDA
- Ensuring appropriate institutional oversight of commitments made under investigator-sponsored INDs and IDE
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
Point of Contact: This email address is being protected from spambots. You need JavaScript enabled to view it.
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
ReGARDD.org : 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.
