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      Association Between Data Sources and US Food and Drug Administration Drug Safety Communications

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          Abstract

          This study describes sources of initial safety signals that that preceded US Food and Drug Administration (FDA) drug safety communications and examines their associations with drug characteristics and subsequent label changes.

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          Most cited references2

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          Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

          Postmarket safety events of novel pharmaceuticals and biologics occur when new safety risks are identified after initial regulatory approval of these therapeutics. These safety events can change how novel therapeutics are used in clinical practice and inform patient and clinician decision making.
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            New "21st Century Cures" Legislation: Speed and Ease vs Science.

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              Author and article information

              Journal
              JAMA Internal Medicine
              JAMA Intern Med
              American Medical Association (AMA)
              2168-6106
              November 01 2019
              November 01 2019
              : 179
              : 11
              : 1590
              Affiliations
              [1 ]Department of Diagnostic Imaging, Sheba Medical Center, Ramat Gan, Israel
              [2 ]Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
              [3 ]Statistics Consulting Unit, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel
              [4 ]Medicine A, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel
              [5 ]Oncology Department, Hospital de la Santa Creu i Sant Pau, Institut d’Investigació Biomèdica Sant Pau, and Universitat Autònoma de Barcelona, Barcelona, Spain
              [6 ]Princess Margaret Cancer Centre, Division of Medical Oncology, University of Toronto, Toronto, Ontario, Canada
              Article
              10.1001/jamainternmed.2019.3066
              6724416
              31479104
              bc15e535-513a-4e31-9d95-3c7662d1e728
              © 2019
              History

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