Building on the Reagan-Udall Foundation for the FDA’s work with FDA and other stakeholders to develop the Expanded Access Navigator, we are 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