Building a national framework for the establishment of regulatory science for drug development : workshop summary /

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"The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to ex...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation
Otros Autores: Lebovitz, Yeonwoo, English, Rebecca A., Claiborne, Anne B.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, ©2011.
Temas:
United States. > Food and Drug Administration.
United States. > Food and Drug Administration
Drug development > United States > Congresses.
Drug Discovery
Clinical Trials as Topic
Drug Approval
Drug Evaluation
Médicaments > Développement > États-Unis > Congrès.
POLITICAL SCIENCE > Government > State & Provincial.
Drug development
United States
Congress
proceedings (reports)
Conference papers and proceedings
Conference papers and proceedings.
Actes de congrès.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Introduction
  • Defining regulatory sciences
  • The urgent need for regulatory science
  • Barriers to enhanced regulatory science
  • Potential models for building a regulatory science infrastructure
  • Challenges in engaging the public policy community
  • Envisioning successsful regulatory science at FDA
  • Considering next steps.

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