Expanded Access

What is Expanded Access?

Expanded Access meaning Synonym(s): Compassionate UseLegal 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. Related Term(s): Food and Drug Administration, Investigational Drug

 

reference: AIDSinfo – Glossary

Tags: ,