The Investigational New Drug (IND) Workshop
Sponsor(s): School of Medicine - Regulatory Affairs, Biomedical Engineering (BME), Department of Surgery, Duke Center for Applied Genomics and Precision Medicine, Duke Clinical and Translational Science Award (CTSA), Duke Clinical Research Institute (DCRI), Duke Office of Clinical Research (DOCR), MEDx, Office of Research Administration (ORA), Office of Research Support (ORS), Pratt School of Engineering, School of Medicine (SOM), and School of Nursing (SON)
Define an investigational drug, including off-label use of FDA approved drugs
Provide guidance on determining when the IND regulations apply to research studies.
Discuss the preparation and submission of IND applications to FDA
Review maintenance and safety reporting requirements
Encourage participant discussion of case scenarios
Contact: Susan Nagorski