Expanded Access
Audio
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 U.S. 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 FDA permission to make an investigational drug available for expanded access.