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

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

"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
Autor principal: Institute of Medicine (U.S.) (-)
Autores Corporativos: Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation, Institute of Medicine (U.S.). Board on Health Sciences Policy, Building a National Framework for the Establishment of Regulatory Science for Drug Development
Otros Autores: Lebovitz, Yeonwoo (-), English, Rebecca A., Claiborne, Anne B.
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press 2011.
Edición:First edition
Materias:
Pharmaceutical policy > United States > Congresses.
Drug development > Government policy > United States > Congresses.
Pharmaceutical industry > Government policy > United States > Congresses.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622408406719
Tabla de Contenidos:
  • ""Front Matter""; ""Reviewers""; ""Contents""; ""Figures and Boxes""; ""Acronyms""; ""Preface""; ""1 Introduction""; ""2 Defining Regulatory Science""; ""3 The Urgent Need for Regulatory Science""; ""4 Barriers to Enhanced Regulatory Science""; ""5 Potential Models for Building a Regulatory Science Infrastructure""; ""6 Challenges in Engaging the Public Policy Community""; ""7 Envisioning Successful Regulatory Science at FDA""; ""8 Considering Next Steps""; ""References""; ""Appendix A: Agenda""; ""Appendix B: Participant Biographies""

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