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Postmarketing Safety-Related Regulatory Actions for New Therapeutic Biologics Approved in the United States 2002-2014: Similarities and Differences With New Molecular Entities.
Bulatao, Ilynn; Pinnow, Ellen; Day, Brendan; Cherkaoui, Sanae; Kalaria, Manish; Brajovic, Sonja; Dal Pan, Gerald.
Afiliação
  • Bulatao I; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Pinnow E; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Day B; School of Medicine, University of Maryland, Baltimore, Maryland, USA.
  • Cherkaoui S; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kalaria M; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Brajovic S; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Dal Pan G; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther ; 108(6): 1243-1253, 2020 12.
Article em En | MEDLINE | ID: mdl-32557564
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Etiology_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Etiology_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2020 Tipo de documento: Article