Last day to withdraw with W from Spring 2025 classes (undergraduates only)

Registration begins for Fall 2025 (7:00 AM); Summer registration continues

Optional make-up day (for February 19 classes)

Registration ends for Fall 2025; Summer registration continues

Drop/Add begins for Fall 2025

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)

Graduate classes end

Graduate reading period

Undergraduate classes and some graduate classes (500-699) end

Undergraduate reading period

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