Expanded access

Expanded Access

Expanded access (pronunciation: /ɪkˈspændɪd ˈæksɛs/), also known as compassionate use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Etymology

The term "expanded access" is derived from the concept of expanding the access to investigational treatments for patients who cannot participate in controlled clinical trials. The term "compassionate use" is used to reflect the intention of this program to provide potentially beneficial treatments to patients in need out of a sense of compassion.

Related Terms

Investigational New Drug (IND): An IND is a new pharmaceutical product that has not yet been approved by the Food and Drug Administration (FDA) for marketing but is proposed for use in experiments to determine its safety and efficacy.

Clinical Trial: A clinical trial is a research study performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention.

Food and Drug Administration (FDA): The FDA is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

Emergency Use Authorization (EUA): An EUA is a legal means for the FDA to approve new drugs or new indications for previously approved drugs during a declared emergency.

Right to Try Act: The Right to Try Act is a U.S. federal law that allows terminally ill patients access to experimental drugs, biologics, and devices that have completed Phase I testing but have not been approved by the FDA.