title: Pharmacovigilance: towards a better understanding of the benefit to risk ratio.
authors.affiliation: Division of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products, Center for Drug Evaluation and Research ODEV, FDA, Rockville, MD 20850, USA.
authors.forename: L S
authors.initials: LS
authors.lastname: Simon
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D018501:Antirheumatic Agents / Q000009:adverse effects*; D006801:Humans; D018570:Risk Assessment; D014481:United States
chemical_list: D018501:Antirheumatic Agents