Expanded Access to Investigational Products

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


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

This presentation will provide an overview of FDA’s Expanded Access Program which permits pre-approval access to drugs in development.  The discussion will address the following:

  • Basic information and definitions for expanded access
  • 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 the program. Submit advance questions or comments to o3is@pitt.edu.

Location and Address

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