Centering the Patient in Meaningful Outcomes and Regulatory Approval.
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: eflewis@partners.org.
Eldrin F
EF
Lewis
D005060:Europe; D006333:Heart Failure; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
European Medicines Agency; Food and Drug Administration; heart failure; patient-reported outcomes; quality of life; regulatory approval