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 email@example.com.
Location and Address
Hillman Cancer Center
Nimick Conference Room, 1st Floor