An Overview of FDA’s Project Facilitate Oncology Expanded Access Program

Description: Expanded access, sometimes called "compassionate use", is a potential pathway for a patient with a serious or immediately life-threatening 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. This enduring material will review the oncology expanded access pathway and Project Facilitate's role in making oncology expanded access more accessible for healthcare and regulatory professionals.