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The Investigational New Drug (IND) Workshop

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