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The Investigational New Drug (IND) Workshop

Feb 10

Friday, February 10, 2023 - 12:00pm to 2:00pm

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Presenter

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

Contact

Susan Nagorski
susan.nagorski@duke.edu