The Investigational New Drug (IND) Workshop


event sponsored by

Office of Regulatory Affairs and Quality &

Duke Clinical and Translational Science Institute (CTSI), Pratt School of Engineering, and School of Medicine (SOM)


Rose Beci and Andrea Burns

-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


United States Focus, Lecture/Talk, Workshop/Short Course, and Research