Expanded Access
Expanded Access, also called compassionate use, is an FDA pathway letting patients with serious conditions and no alternatives receive an investigational drug or device outside a clinical trial when they cannot otherwise qualify for or access ongoing studies.
What is Expanded Access?
Expanded Access, also known as compassionate use, is a U.S. Food and Drug Administration (FDA) pathway that allows patients with serious or life-threatening conditions to receive an investigational drug or device outside of a clinical trial. It applies when no satisfactory approved treatment exists and the patient cannot enroll in an ongoing study.
The pathway is intended for situations where the potential benefit to the individual patient justifies the risks of using a product that has not yet completed the normal approval process. It requires appropriate authorization and oversight rather than unrestricted use.
Why does Expanded Access matter?
Expanded access offers a route to potentially helpful therapies for patients who have run out of approved options and cannot otherwise obtain the investigational product. For seriously ill people, it can represent a meaningful alternative when standard care has been exhausted.
At the same time, the pathway is deliberately bounded to protect patient safety and to preserve the integrity of the clinical trials that ultimately establish whether a product works. Balancing individual access against the need for rigorous evidence is a central tension the framework is designed to manage.
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