Expanded Access

Expanded Access, also known as compassionate use, allows patients with serious or life-threatening conditions to receive investigational treatments—drugs or therapies not yet approved by regulatory agencies—outside of clinical trials. This program provides access when no comparable approved treatments are available and when the potential benefits outweigh the risks. It is typically arranged through the patient’s doctor and the drug manufacturer, with oversight from regulatory bodies. Expanded Access aims to help patients in urgent need while gathering additional safety data for the investigational product.