title: FDA guidance on patient reported outcomes.
authors.forename: Jane
authors.initials: J
authors.lastname: Speight
authors.forename: Shalleen M
authors.initials: SM
authors.lastname: Barendse
mesh_terms: D004345:Drug Industry; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000592:standards*; D017060:Patient Satisfaction; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*