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Volumn 171, Issue 10, 2011, Pages 944-946

A Quantitative analysis of adverse events and "overwarning" in drug labeling

Author keywords

[No Author keywords available]

Indexed keywords

DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR;

EID: 79957577277     PISSN: 00039926     EISSN: 15383679     Source Type: Journal    
DOI: 10.1001/archinternmed.2011.182     Document Type: Letter
Times cited : (37)

References (9)
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    • Drug labeling revisions-guaranteed to fail
    • Woosley RL, Woosley RL. Drug labeling revisions-guaranteed to fail? JAMA. 2000;284(23):3047-3049.
    • (2000) JAMA , vol.284 , Issue.23 , pp. 3047-3049
    • Woosley, R.L.1    Woosley, R.L.2
  • 2
    • 33744961171 scopus 로고    scopus 로고
    • Highlights and a hidden hazard-the FDA's new labeling regulations
    • Avorn J, Shrank W. Highlights and a hidden hazard-the FDA's new labeling regulations. N Engl J Med. 2006;354(23):2409-2411.
    • (2006) N Engl J Med , vol.354 , Issue.23 , pp. 2409-2411
    • Avorn, J.1    Shrank, W.2
  • 3
    • 33644872081 scopus 로고    scopus 로고
    • Requirements on content and format of labeling for human prescription drug and biological products. Final rule
    • Food and Drug Administration, HHS
    • Food and Drug Administration, HHS. Requirements on content and format of labeling for human prescription drug and biological products. Final rule. Fed Regist. 2006;71(15):3921-3997.
    • (2006) Fed Regist , vol.71 , Issue.15 , pp. 3921-3997
  • 4
    • 33747165708 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Rockville, MD: Food and Drug Administration
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products-Content and Format. Rockville, MD: Food and Drug Administration; 2006.
    • (2006) Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products-Content and Format
  • 5
    • 77954726498 scopus 로고    scopus 로고
    • US National Library of Medicine, Accessed December 17
    • US National Library of Medicine. About DailyMed. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed December 17, 2009.
    • (2009) About DailyMed
  • 6
    • 57149141744 scopus 로고    scopus 로고
    • Structured product labeling improves detection of drugintolerance issues
    • Schadow G. Structured product labeling improves detection of drugintolerance issues. J Am Med Inform Assoc. 2009;16(2):211-219.
    • (2009) J Am Med Inform Assoc , vol.16 , Issue.2 , pp. 211-219
    • Schadow, G.1
  • 7
    • 84964936658 scopus 로고    scopus 로고
    • ADESSA: A Real-Time Decision Support Service for Delivery of Semantically Coded Adverse Drug Event Data
    • Duke JD, Friedlin J. ADESSA: A Real-Time Decision Support Service for Delivery of Semantically Coded Adverse Drug Event Data. AMIA Annu Symp Proc. 2010;2010:177-181.
    • (2010) AMIA Annu Symp Proc , vol.2010 , pp. 177-181
    • Duke, J.D.1    Friedlin, J.2
  • 8
    • 79957578825 scopus 로고    scopus 로고
    • US National Library of Medicine, Accessed November 14, 2009
    • US National Library of Medicine. 2008AB National Drug File-Reference Terminology Source Information. 2009. http://www.nlm.nih.gov/research/umls/sourcereleasedocs/2008AB/NDFRT/attributes.html. Accessed November 14, 2009.
    • (2009) 2008AB National Drug File-Reference Terminology Source Information
  • 9
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    • Center for Drug Evaluation and Research, Accessed February 9
    • Center for Drug Evaluation and Research. Drugs@FDA Data Files. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm. Accessed February 9, 2010.
    • (2010) Drugs@FDA Data Files


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.