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Expanded access

A process for a doctor to request an unapproved treatment for a seriously ill patient.


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Expanded Access is a path for a patient with an immediately life-threatening or serious disease or condition to access an investigational medical product (like a drug, biologic, or medical device). Expanded Access can make treatment outside of clinical trials possible when no other treatments are available and there is no clinical trial for the patient to join.

Expanded Access is also called “compassionate use.” Expanded Access is a program for doctors to request treatments that are not yet approved for seriously ill patients. This request is made by a patient’s doctors using the Expanded Access application. The
company that makes the experimental drug also has to approve the request.