Silver Spring, MD (Public Statement) – For patients with serious or im­medi­ately life-threatening diseases, the FDA remains committed to enhancing access to promising inves­ti­ga­tional medicines for those unable to access prod­ucts through clin­i­cal trials. This is the mission of our expanded access pro­gram. The agency is dedicated to these pur­poses, and it has been for more than three decades.

We’ve taken many steps to im­prove our process through which patients can access promising inves­ti­ga­tional drugs. We under­stand that treat­ment de­ci­sions for those facing terminal illnesses are best made by patients and families, with …