skip navigation

Skip Nav

Education Materials

Education Materials

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 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.

See Related Term(s): Food and Drug Administration, Investigational Drug


Download Glossary

Back to Top