Expanded Access to Investigational Products

July 23, 2018 - 9:00am to 10:00am

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.

No registration required. Submit advance questions or comments to o3is@pitt.edu.

Location and Address

Children's Hospital of UPMC
Rangos Research Center
3rd Floor, Rooms B and C