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Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.
Sacks, Leonard V; Shamsuddin, Hala H; Yasinskaya, Yuliya I; Bouri, Khaled; Lanthier, Michael L; Sherman, Rachel E.
Afiliação
  • Sacks LV; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Shamsuddin HH; Office of Antimicrobial Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Yasinskaya YI; Office of Antimicrobial Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
  • Bouri K; Office of Critical Path Programs, Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland.
  • Lanthier ML; Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland.
  • Sherman RE; Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
JAMA ; 311(4): 378-84, 2014.
Article em En | MEDLINE | ID: mdl-24449316
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Aplicação de Novas Drogas em Teste Tipo de estudo: Observational_studies / Prognostic_studies País/Região como assunto: America do norte Idioma: En Ano de publicação: 2014 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: United States Food and Drug Administration / Aplicação de Novas Drogas em Teste Tipo de estudo: Observational_studies / Prognostic_studies País/Região como assunto: America do norte Idioma: En Ano de publicação: 2014 Tipo de documento: Article