A risk-characterization framework for decision-making at the Food and Drug Administration /

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With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that co...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: National Academies (U.S.). Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington D.C. : National Academies Press, [2011]
Colección:Online access: National Academy of Sciences National Academies Press.
Online access: NCBI NCBI Bookshelf.
Temas:
United States. > Food and Drug Administration > Case studies.
United States. > Food and Drug Administration.
United States. > Food and Drug Administration
Decision making > United States > Case studies.
Product safety > United States > Decision making > Case studies.
Risk assessment > United States > Case studies.
Decision making.
Risk Assessment > methods
Consumer Product Safety
Drug Approval
Decision Making
United States Government Agencies
Prise de décision > États-Unis > Études de cas.
Produits commerciaux > Sécurité > États-Unis > Prise de décision > Études de cas.
Évaluation du risque > États-Unis > Études de cas.
Prise de décision.
decision making.
POLITICAL SCIENCE > Government > State & Provincial.
Decision making
Risk assessment
United States
Case studies
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Introduction
  • A Risk-Characterization Framework
  • Case Study of a Mitigation-Selection Decision
  • Case Study of a Targeting Decision
  • Case Study of a Strategic-Investment Decision
  • Case Study of a Targeting Decision That Spans Food and Drug Administration Centers
  • Conclusions and Future Directions
  • A: Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks
  • B: Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II
  • C: Scenarios Provided by the U.S. Food and Drug Administration to the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II
  • D: Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II
  • E: Factors Hypothesized as Important in Understanding Risk.

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