A service of the U.S. National Institutes of Health

Glossary Definition

EXPANDED ACCESS

A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. One of several Study Types.

For more information on expanded access programs, please visit the FDA Web site at http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/default.htm.