Expanded Access to Investigational Products and Overview of Commonly Used FDA Forms

July 18, 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 (permits pre-approval access to drugs in development) and commonly used FDA forms in the submission of Investigational New Drug applications and subsequent FDA correspondence. 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.
  • Forms 1571, 1572, 3500a, 3674 and 3926

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

Location and Address

Hillman Cancer Center
Nimick Conference Room, 1st Floor