Report on Leveraging Real-World Treatment Experience from Expanded Access Protocols

Recently released, the Public Meeting Report "Leveraging Real-World Treatment Experience from Expanded Access Protocols" .  This report provides a comprehensive summary of the use of real-world treatment experience discussed by stakeholder groups, hosted by the FDA Reagan-Udall Foundation on November 19, 2018.  

The key messaging can be summarized here:  "While not a requirement for regulatory submission, expanded access presents an opportunity to gather real-world data that can improve knowledge and help modernize drug development processes."