Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available
View this resource Bookmark this resource
National programs for early access
Published by IRDiRC
Regulatory AffairsClinical DevelopmentCompassionate Use