Challenges for the FDA : the future of drug safety : workshop summary

Challenges for the FDA the future of drug safety : workshop summary

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Detalles Bibliográficos
Autor principal: Symposium on the Future of Drug Safety: Challenges for the FDA (-)
Autores Corporativos: Symposium on the Future of Drug Safety: Challenges for the FDA Corporate Author (corporate author), Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation
Otros Autores: Pray, Leslie A. (-), Robinson, Sally
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, DC : National Academies Press c2007.
Edición:1st ed
Materias:
United States. > Food and Drug Administration > Rules and practice.
Drugs > United States > Testing > Congresses.
Drugs > United States > Safety measures > Congresses.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622157506719
Tabla de Contenidos:
  • FrontMatter
  • Reviewers
  • Preface
  • Contents
  • Tables, Figures, and Boxes
  • Summary
  • 1 Introduction
  • 2 Addressing the FDA's Resource Challenges
  • 3 Strengthening the Scientific Base of the Agency
  • 4 Integrating Pre- and Postmarket Review
  • 5 Enhancing Postmarket Safety Monitoring
  • 6 Conducting Confirmatory Drug Safety and Efficacy Studies
  • 7 Enhancing the Value of Clinical Trial Registration
  • 8 Enhancing Postmarket Regulation and Enforcement
  • 9 Looking to the Future
  • References
  • Appendixes
  • Appendix A Workshop Agenda
  • Appendix B Speaker Biographies.

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