SEAN TURBEVILLE

Finally, there is a single resource you can turn to that will provide the information required to initiate a compassionate use/expanded access program... Compassionate use or expanded access refer to the means for providing unapproved medications for treating patients with serious medical conditions when no other treatments are available. Governments around the world have created provisions for granting access to unlicensed or investigational drugs to patients who have exhausted all available treatment options or have no treatment alternatives in their country. These pathways are grouped under the labels of compassionate use programs (CUP), expanded access programs (EAP), or single named patient programs (NPP)... The Global Guide to Compassionate Use Programs was developed over four years by industry, government, regulatory, operational and pharmacovigilance experts with decades of combined global experience.