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A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.
Beaver, Julia A; Howie, Lynn J; Pelosof, Lorraine; Kim, Tamy; Liu, Jinzhong; Goldberg, Kirsten B; Sridhara, Rajeshwari; Blumenthal, Gideon M; Farrell, Ann T; Keegan, Patricia; Pazdur, Richard; Kluetz, Paul G.
Afiliação
  • Beaver JA; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland.
  • Howie LJ; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland.
  • Pelosof L; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland.
  • Kim T; Center for Drug Evaluation and Research and Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.
  • Liu J; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland.
  • Goldberg KB; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland.
  • Sridhara R; Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland.
  • Blumenthal GM; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland.
  • Farrell AT; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland.
  • Keegan P; Office of Hematology and Oncology Products, US Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Center for Drug Evaluation and Research and Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz PG; Center for Drug Evaluation and Research and Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland.
JAMA Oncol ; 4(6): 849-856, 2018 06 01.
Article em En | MEDLINE | ID: mdl-29494733

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Produtos Biológicos / Aprovação de Drogas / Antineoplásicos Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: JAMA Oncol Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Produtos Biológicos / Aprovação de Drogas / Antineoplásicos Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: JAMA Oncol Ano de publicação: 2018 Tipo de documento: Article