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

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


Point of Contact: Amanda Wood

Request help with IND / IDE Applications


More Information

Investigational New Drugs

Investigational Device Exemptions

Expanded Access / Emergency IND and IDE Applications

IND & IDE Templates and Forms

ClinicalTrials.gov

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, and RTI.