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Investigational New Drug Workshop

March 5 @ 9:00 am - 11:00 am

This workshop will:
• 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

Registration required.