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

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  • Monica A. Muñoz

    (US Food and Drug Administration)

  • Gerald J. Dal Pan

    (US Food and Drug Administration)

Abstract

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  • Monica A. Muñoz & Gerald J. Dal Pan, 2019. "The Impact of Litigation-Associated Reports on Signal Identification in the US FDA’s Adverse Event Reporting System," Drug Safety, Springer, vol. 42(10), pages 1199-1201, October.
  • Handle: RePEc:spr:drugsa:v:42:y:2019:i:10:d:10.1007_s40264-019-00834-1
    DOI: 10.1007/s40264-019-00834-1
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    References listed on IDEAS

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    1. James R. Rogers & Ameet Sarpatwari & Rishi J. Desai & Justin M. Bohn & Nazleen F. Khan & Aaron S. Kesselheim & Michael A. Fischer & Joshua J. Gagne & John G. Connolly, 2019. "Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration’s Adverse Event Reporting System," Drug Safety, Springer, vol. 42(1), pages 85-93, January.
    2. Lisa Harinstein & Dipti Kalra & Cindy M. Kortepeter & Monica A. Muñoz & Eileen Wu & Gerald J. Dal Pan, 2019. "Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance," Drug Safety, Springer, vol. 42(5), pages 649-655, May.
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    1. Peter Arlett, 2019. "Building an Evidence Base on the Place of Industry-Sponsored Programs in Drug Safety Surveillance," Drug Safety, Springer, vol. 42(5), pages 581-582, May.
    2. Kathryn Marwitz & S. Christopher Jones & Cindy M. Kortepeter & Gerald J. Dal Pan & Monica A. Muñoz, 2020. "An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System," Drug Safety, Springer, vol. 43(5), pages 457-465, May.

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