title: FDA implementation of the expanded access program in the United States.
authors.affiliation: a U.S. Food and Drug Administration.
authors.forename: Michelle
authors.initials: M
authors.lastname: Roth-Cline
authors.forename: Robert
authors.initials: R
authors.lastname: Nelson
mesh_terms: D057176:Compassionate Use Trials; D003625:Data Collection; D032984:Ethics, Research; D019317:Evidence-Based Medicine; D006801:Humans; D028681:Moral Obligations; D010361:Patients