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.
- 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
Point of Contact: Amanda Wood