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Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration's Adverse Event Reporting System.
Rogers, James R; Sarpatwari, Ameet; Desai, Rishi J; Bohn, Justin M; Khan, Nazleen F; Kesselheim, Aaron S; Fischer, Michael A; Gagne, Joshua J; Connolly, John G.
Affiliation
  • Rogers JR; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.
  • Sarpatwari A; Department of Biomedical Informatics, Columbia University, New York, NY, USA.
  • Desai RJ; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.
  • Bohn JM; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.
  • Khan NF; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.
  • Kesselheim AS; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.
  • Fischer MA; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.
  • Gagne JJ; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA.
  • Connolly JG; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA. jgagne@bwh.harvard.edu.
Drug Saf ; 42(1): 85-93, 2019 01.
Article in En | MEDLINE | ID: mdl-30066315
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: United States Food and Drug Administration / Adverse Drug Reaction Reporting Systems / Lawyers / Drug-Related Side Effects and Adverse Reactions Type of study: Diagnostic_studies / Prognostic_studies Limits: Humans Country/Region as subject: America do norte Language: En Journal: Drug Saf Journal subject: TERAPIA POR MEDICAMENTOS / TOXICOLOGIA Year: 2019 Document type: Article Affiliation country: United States Country of publication: New Zealand
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: United States Food and Drug Administration / Adverse Drug Reaction Reporting Systems / Lawyers / Drug-Related Side Effects and Adverse Reactions Type of study: Diagnostic_studies / Prognostic_studies Limits: Humans Country/Region as subject: America do norte Language: En Journal: Drug Saf Journal subject: TERAPIA POR MEDICAMENTOS / TOXICOLOGIA Year: 2019 Document type: Article Affiliation country: United States Country of publication: New Zealand