Expanded Access programs present inherent challenges for sponsors navigating investigational therapies.
As demand for compassionate use grows, sponsors must balance timely patient access with FDA compliance, safety oversight, and protection of clinical trial integrity. The focus is shifting from reactive, case-by-case handling to a structured, sponsor-led approach that strengthens governance and regulatory readiness.
Read our guide to explore more about:
- How to protect ongoing clinical trials while enabling Expanded Access
- How to establish clear governance, triage, and escalation pathways
- How to prepare for scale-up from individual patient access to Treatment IND
- How to implement robust safety monitoring and FDA reporting frameworks