Speaker: Cynthia Kern
Director, Office for Investigator-Sponsored IND and IDE Support
This session will provide an overview of the process for submitting an Emergency Use Request to the FDA for expanded access to an investigational product. The discussion will provide detailed information on the approach for obtaining access to investigational products and how the O3IS office provides support in this area.
- What is expanded access?
- Who can request expanded access?
- What to submit to the FDA?
- Where to submit?
- What to submit to the University of Pittsburgh IRB?
Location and Address
Learning Resource Center, Room 305
3500 Fifth Avenue, Pittsburgh, PA 15213