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
Descripción
Sumario: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 collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations.
Notas:Title from PDF title page.
Descripción Física:1 online resource (1 PDF file (xiv, 192 pages)) : illustrations
Bibliografía:Includes bibliographical references.
ISBN:9780309212816
0309212812
1283135167
9781283135160

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