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 firstname.lastname@example.org.
Location and Address
Children's Hospital of UPMC
Rangos Research Center
3rd Floor, Rooms B and C