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

Author: National Academies (U.S.). Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II,
Publisher: Washington D.C. : National Academies Press, [2011]
Edition/Format:   eBook : Document : EnglishView all editions and formats
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  Read more...
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Genre/Form: Electronic books
Case studies
Additional Physical Format: Print version:
Risk-characterization framework for decision-making at the Food and Drug Administration.
Washington, D.C. : National Academies Press, ©2011
(OCoLC)741786294
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: National Academies (U.S.). Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II,
ISBN: 9780309212816 0309212812 1283135167 9781283135160
OCLC Number: 741650502
Notes: Title from PDF title page.
Description: 1 online resource (1 PDF file (xiv, 192 pages)) : illustrations
Contents: 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.
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.

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