We provide full-service regulatory support and assistance in navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.

IND & IDE Application Support

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 recording | 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 recording | 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 recording | 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 recording | 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.

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Contact Us


Brinkhous-Bullitt, 2nd floor
160 N. Medical Drive
Chapel Hill, NC 27599

919.966.6022
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CitE and SUBMit CTSA Grant number - UL1TR002489

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