Managed Access is a term that refers to the provision of an unapproved product (either still investigational or not approved/available in the country of request) to a patient with a serious or life-threatening condition who has exhausted available treatment options and cannot join a clinical trial. It may also refer to the provision of continued access to an unapproved product following the conclusion of a clinical trial. Managed Access follows a regulatory pathway in a country or region where the regulations allow for provision of unapproved product outside of clinical trials under certain conditions.