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. 2019 Oct;42(10):1199-1201.
doi: 10.1007/s40264-019-00834-1.

The Impact of Litigation-Associated Reports on Signal Identification in the US FDA's Adverse Event Reporting System

Affiliations

The Impact of Litigation-Associated Reports on Signal Identification in the US FDA's Adverse Event Reporting System

Monica A Muñoz et al. Drug Saf. 2019 Oct.
No abstract available

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References

    1. 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. - DOI - PubMed
    1. US FDA Adverse Event Reporting System (FAERS) Public Dashboard. Available at: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Survei... . Accessed 4 Apr 2019.
    1. DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat. 1999;53:177–90.
    1. 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. - DOI - PubMed
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