Optional make-up day (for February 19 classes)

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

Optional make-up day (for February 20 classes)

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 scenarios • Encourage participant discussion of case scenarios