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The FDA Oncology Center of Excellence Scientific Collaborative: Charting a Course for Applied Regulatory Science Research in Oncology.
Schneider, Julie A; Gong, Yutao; Goldberg, Kirsten B; Kluetz, Paul G; Theoret, Marc R; Amiri-Kordestani, Laleh; Beaver, Julia A; Fashoyin-Aje, Lola; Gormley, Nicole J; Jaigirdar, Adnan A; Lemery, Steven J; Mishra-Kalyani, Pallavi S; Reaman, Gregory H; Rivera, Donna R; Rubinstein, Wendy S; Singh, Harpreet; Sridhara, Rajeshwari; Pazdur, Richard.
Afiliação
  • Schneider JA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gong Y; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz PG; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Theoret MR; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Amiri-Kordestani L; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Beaver JA; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Fashoyin-Aje L; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gormley NJ; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Jaigirdar AA; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Lemery SJ; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Mishra-Kalyani PS; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Reaman GH; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rivera DR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rubinstein WS; Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Singh H; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Sridhara R; Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 27(19): 5161-5167, 2021 10 01.
Article em En | MEDLINE | ID: mdl-33910935
ABSTRACT
The FDA Oncology Center of Excellence (OCE) is a leader within the agency in scientific outreach activities and regulatory science research. On the basis of analysis of scientific workshops, internal meetings, and publications, the OCE identified nine scientific priority areas and one cross-cutting area of high interest for collaboration with external researchers. This article describes the process for identifying these scientific interest areas and highlights funded and unfunded opportunities for external researchers to work with FDA staff on critical regulatory science challenges.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Relatório de Pesquisa / Oncologia Limite: Humans Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2021 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Relatório de Pesquisa / Oncologia Limite: Humans Idioma: En Revista: Clin Cancer Res Assunto da revista: NEOPLASIAS Ano de publicação: 2021 Tipo de documento: Article