Duke University School of Medicine Office of Regulatory Affairs and Quality

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.

This workshop will: • Discuss FDA’s approach to regulation of devices in clinical studies and for marketing • Provide guidance on when the IDE regulations apply and discuss possible exemptions • Review significant risk and non-significant risk device studies • Discuss the preparation, submission, and maintenance of IDE applications • Encourage participant discussion of case... Read more »