Alison Bateman-House
Associate Professor, Division of Medical Ethics, Department of Population Health NYU Grossman School of Medicine
Seminars
Wednesday 25th March 2026
Expanded Access in 2026: New Guidance, Evolving Expectations, and What People Need to Know
8:30 am
- What has changed with the latest FDA Expanded Access guidance and what this means for sponsor decision‑making and risk‑benefit considerations?
- How evolving expectations around post‑trial access, use of real‑world data, and charging may reshape Expanded Access strategies
- Opportunities for sponsors, with key practical suggestions for program design, governance, and stakeholder engagement
