Friday, April 11, 2025
12:00 pm – 2:00 pm
Zoom
Presenter: Rachel Johnson, PhD, RAC 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
Contact
Susan Nagorski
susan.nagorski@duke.edu