Expanded Access to Investigational Products

February 12, 2018 - 11:00am to 12:00pm

Speaker: Cynthia Kern, Director, Officer of Investigator-Sponsored IND and IDE Support

This presentation will provide an overview of FDA’s Expanded Access Program.  The discussion will address the following:

  • basic information and definitions for expanded access
  • a review of expanded access categories
  • required FDA forms for expanded access submissions
  • an overview of FDA expectations for physicians who apply to treat patients using this pathway.

Click here to register for program as seating is limited. Submit advance questions or comments to o3is@pitt.edu.

Location and Address

RCCO Learning Resource Center, Room 305
Hieber Building, 3500 Fifth Avenue