FolkersKMBateman-HouseA. Improving expanded access in the United States: the role of the institutional review board. Therapeutic Innovation & Regulatory Science. 2018;52(3):285–293.
Expanded access to investigational drugs for treatment use—questions and answers, guidance for industry. Food and Drug Administration. https://www.fda.gov/downloads/drugs/guidances/ucm351261.pdf. Published June 2016. Updated October 2017. Accessed May 11, 2018.