Building on the Reagan-Udall Foundation for the FDA’s work with FDA and other stakeholders to develop the Expanded Access Navigator, the Reagan-Udall Foundation is convening stakeholders from government, industry, academia and patient groups to discuss process issues that include:
- Increase understanding of the expanded access program
- Identify and discuss strengths, challenges and opportunities
- Discuss what could be the optimum balance between providing access for treatment and obtaining data in support of regulatory applications
- How could the data be leveraged?
- How could it be optimized without overburdening companies and providers?
- Provide input to FDA on future communications regarding utilizing data from Expanded Access (investigational) protocols