Expanded Access Policy

Oftentimes, patients who are suffering from severe or life-threatening conditions may seek access to an investigational therapy prior to those therapies being approved by a regulatory body. In these cases, patients may make a request directly to a company to obtain access to a therapy through a program called expanded access, which is sometimes also referred to as compassionate use. Expanded access is defined as use of an experimental drug outside of a clinical trial and requires the approval of a regulatory body like the Food and Drug Administration in the United States, or the European Medicines Agency in the European Union.