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The Investigational New Drug (IND) Workshop

November 19, 2019 - 9:00am to 12:00pm
Rachel Johnson, PhD, RAC and Daniel Tonkin, PhD, RAC

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.