Coverart for item
The Resource A risk-characterization framework for decision-making at the Food and Drug Administration, Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, Board on Environmental Studies and Toxicolgoy, Division on Earth and Life Studies, National Research Council, Institute of Medicine, National Research Council of the National Academies

A risk-characterization framework for decision-making at the Food and Drug Administration, Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, Board on Environmental Studies and Toxicolgoy, Division on Earth and Life Studies, National Research Council, Institute of Medicine, National Research Council of the National Academies

Label
A risk-characterization framework for decision-making at the Food and Drug Administration
Title
A risk-characterization framework for decision-making at the Food and Drug Administration
Statement of responsibility
Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, Board on Environmental Studies and Toxicolgoy, Division on Earth and Life Studies, National Research Council, Institute of Medicine, National Research Council of the National Academies
Creator
Contributor
Author
Provider
Subject
Genre
Language
eng
Summary
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
Cataloging source
NLM
Funding information
This project was supported by Contract HHSP23320042509XI/HHSP233200800001T between the National Academy of Sciences and the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
Index
no index present
LC call number
RA401.A3
LC item number
R57 2011eb
Literary form
non fiction
Nature of contents
  • standards specifications
  • bibliography
NLM call number
WA 289
http://bibfra.me/vocab/lite/organizationName
National Academies (U.S.)
http://library.link/vocab/relatedWorkOrContributorName
ebrary
http://library.link/vocab/subjectName
  • United States
  • United States
  • United States
  • United States
  • Consumer Product Safety
  • Risk Assessment
  • Decision Making
  • Drug Approval
  • United States Government Agencies
  • Decision making
  • Product safety
  • Risk assessment
  • POLITICAL SCIENCE
  • Management
  • Public health
  • United States
Label
A risk-characterization framework for decision-making at the Food and Drug Administration, Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, Board on Environmental Studies and Toxicolgoy, Division on Earth and Life Studies, National Research Council, Institute of Medicine, National Research Council of the National Academies
Instantiates
Publication
Note
Title from PDF t.p
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • 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
  • 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:
Dimensions
unknown
Extent
1 online resource (1 PDF file (xiv, 192 pages))
Form of item
electronic
Isbn
9781283135160
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations.
Specific material designation
remote
System control number
  • (OCoLC)741650502
  • (OCoLC)ocn741650502
Label
A risk-characterization framework for decision-making at the Food and Drug Administration, Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, Board on Environmental Studies and Toxicolgoy, Division on Earth and Life Studies, National Research Council, Institute of Medicine, National Research Council of the National Academies
Publication
Note
Title from PDF t.p
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • 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
  • 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:
Dimensions
unknown
Extent
1 online resource (1 PDF file (xiv, 192 pages))
Form of item
electronic
Isbn
9781283135160
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations.
Specific material designation
remote
System control number
  • (OCoLC)741650502
  • (OCoLC)ocn741650502

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