Expanded Access: Past, Present and Future Improvements

Additional Concepts, Closeout, EAP, Execution, Forecasting / Planning

Expanded access is a program that provides patients with investigational medicinal products (IMP) for treatment purposes. These patients are often excluded from clinical trials but could still benefit from access to the drugs, biologics or medical devices being tested. While, in concept, expanded access represents a way to help more patients receive new and developing treatments, in reality, the process is complex and often misunderstood.

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