References
Rogers JR, Sarpatwari A, Desai RJ, Bohn JM, Khan NF, Kesselheim AS, et al. Effect of lawyer-submitted reports on signals of disproportional reporting in the food and drug administration’s adverse event reporting system. Drug Saf. 2019;42(1):85–93.
US FDA Adverse Event Reporting System (FAERS) Public Dashboard. Available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 4 Apr 2019.
DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177–90.
Harinstein L, Kalra D, Kortepeter CM, Munoz MA, Wu E, Dal Pan GJ. Evaluation of postmarketing reports from industry-sponsored programs in drug safety surveillance. Drug Saf. 2019;42(5):649–55.
Klein K, Scholl JHG, De Bruin ML, van Puijenbroek EP, Leufkens HGM, Stolk P. When more is less: an exploratory study of the precautionary reporting bias and its impact on safety signal detection. Clin Pharmacol Ther. 2018;103(2):296–303.
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Monica A. Muñoz and Gerald J. Dal Pan have no conflicts of interest to declare.
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Muñoz, M.A., Dal Pan, G.J. The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System. Drug Saf 42, 1199–1201 (2019). https://doi.org/10.1007/s40264-019-00834-1
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DOI: https://doi.org/10.1007/s40264-019-00834-1