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Sources of Evidence Triggering and Supporting Safety-Related Labeling Changes: A 10-Year Longitudinal Assessment of 22 New Molecular Entities Approved in 2008 by the US Food and Drug Administration.
Croteau, David; Pinnow, Ellen; Wu, Eileen; Muñoz, Monica; Bulatao, Ilynn; Dal Pan, Gerald.
Afiliação
  • Croteau D; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA. david.croteau@fda.hhs.gov.
  • Pinnow E; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA.
  • Wu E; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA.
  • Muñoz M; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA.
  • Bulatao I; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA.
  • Dal Pan G; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, MD, 20993, Silver Spring, USA.
Drug Saf ; 45(2): 169-180, 2022 02.
Article em En | MEDLINE | ID: mdl-35113347
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vigilância de Produtos Comercializados / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Tipo de estudo: Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vigilância de Produtos Comercializados / Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Tipo de estudo: Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article