Expanded Access

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Synonym(s):
Compassionate Use
Legal use of an investigational drug outside of a clinical trial to treat a person who has a serious or immediately life-threatening disease and who has no approved treatment options. The Food and Drug Administration (FDA) regulates expanded access to investigational drugs on a case-by-case basis for an individual patient or groups of patients who do not meet criteria to participate in a clinical trial. Drug companies must have permission from the FDA to make an investigational drug available for expanded access.

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