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IND/IDE Navigation and Regulatory Guidance

Announcements and Articles


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 Issis Kelly Pumarol, MD. 

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

To request a IND/IDE FDA submission consultation please use the CTSI Service Request Form. For questions, contact Dr. Issis Kelly Pumarol at ikellypu@wakehealth.edu or 336-716-8372.


ReGARDD

The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are comprised of regulatory affairs specialists and experts from North Carolina Institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel HillDuke UniversityWake Forest School of Medicine, and RTI International.

 

Find out more at the ReGARDD website here.

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