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IND/IDE Navigation and Regulatory Guidance

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IND/IDE Navigation Services

The CTSI offers regulatory support and assistance navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications. Review instructions on how to register your IND/IDE.

Registrations and support services are provided by IND/IDE Navigator Heather Hatcher, PhD. 

Available 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 WFBMC 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

To request a IND/IDE FDA submission consultation please use the CTSI Service Request Form. For questions, contact Dr. Heather Hatcher at hhatcher@wakehealth.edu or 336-716-3993.