title: Building comparative efficacy and tolerability into the FDA approval process.
authors.affiliation: University of Rochester School of Medicine and Dentistry, Rochester, New York, USA. alec_oconnor@urmc.rochester.edu
authors.forename: Alec B
authors.initials: AB
authors.lastname: O'Connor
mesh_terms: D057186:Comparative Effectiveness Research; D018795:Device Approval / Q000592:standards*; D017277:Drug Approval / Q000458:organization & administration*; D011356:Product Labeling; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration