Building comparative efficacy and tolerability into the FDA approval process.
O'Connor
Alec B
AB
University of Rochester School of Medicine and Dentistry, Rochester, New York, USA. alec_oconnor@urmc.rochester.edu
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