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

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