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005 20160527041129.8
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008 140702s2011 dcua obt 000 0 eng
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019 742515383|a743413565|a816844562|a923283476
020 9780309212816
020 0309212812
020 1283135167
020 9781283135160
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082 04 353.9/970973|223
090 RA401.A3|bR57 2011eb
110 2 National Academies (U.S.).|bCommittee on Ranking FDA
Product Categories Based on Health Consequences, Phase II,
|0https://id.loc.gov/authorities/names/no2011111144
|eauthor.
245 12 A risk-characterization framework for decision-making at
the Food and Drug Administration /|cCommittee 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.
264 1 Washington D.C. :|bNational Academies Press,|c[2011]
300 1 online resource (1 PDF file (xiv, 192 pages)) :
|billustrations
336 text|btxt|2rdacontent
337 computer|bc|2rdamedia
338 online resource|bcr|2rdacarrier
347 text file|2rdaft
500 Title from PDF title page.
504 Includes bibliographical references.
505 00 |tIntroduction --|tA Risk-Characterization Framework --
|tCase Study of a Mitigation-Selection Decision --|tCase
Study of a Targeting Decision --|tCase Study of a
Strategic-Investment Decision --|tCase Study of a
Targeting Decision That Spans Food and Drug Administration
Centers --|tConclusions and Future Directions --|gA:
|tLetter Report on the Development of a Model for Ranking
FDA Product Categories on the Basis of Health Risks --|gB:
|tStatement of Task for the Committee on Ranking FDA
Product Categories Based on Health Consequences, Phase II
--|gC:|tScenarios Provided by the U.S. Food and Drug
Administration to the Committee on Ranking FDA Product
Categories Based on Health Consequences, Phase II --|gD:
|tBiographic Information on the Committee on Ranking FDA
Product Categories Based on Health Consequences, Phase II
--|gE:|tFactors Hypothesized as Important in Understanding
Risk.
520 3 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.
536 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.
588 0 Version viewed October 3, 2014.
590 eBooks on EBSCOhost|bEBSCO eBook Subscription Academic
Collection - North America
610 10 United States.|bFood and Drug Administration|0https://
id.loc.gov/authorities/names/n80126147|vCase studies.
|0https://id.loc.gov/authorities/subjects/sh99001484
610 10 United States.|bFood and Drug Administration.|0https://
id.loc.gov/authorities/names/n80126147
610 14 United States.|bFood and Drug Administration|xManagement.
610 17 United States.|bFood and Drug Administration.|2fast|0https
://id.worldcat.org/fast/549734
650 0 Decision making|zUnited States|0https://id.loc.gov/
authorities/subjects/sh2009123007|vCase studies.|0https://
id.loc.gov/authorities/subjects/sh99001484
650 0 Product safety|0https://id.loc.gov/authorities/subjects/
sh85107207|zUnited States|0https://id.loc.gov/authorities/
names/n78095330-781|xDecision making|0https://id.loc.gov/
authorities/subjects/sh99005493|vCase studies.|0https://
id.loc.gov/authorities/subjects/sh99001484
650 0 Risk assessment|0https://id.loc.gov/authorities/subjects/
sh87002638|zUnited States|0https://id.loc.gov/authorities/
names/n78095330-781|vCase studies.|0https://id.loc.gov/
authorities/subjects/sh99001484
650 7 Decision making.|2fast|0https://id.worldcat.org/fast/
889035
650 7 Product safety.|2fast|0https://id.worldcat.org/fast/
1078248
650 7 Risk assessment.|2fast|0https://id.worldcat.org/fast/
1098146
650 12 Risk Assessment|xmethods.|0https://id.nlm.nih.gov/mesh/
D018570Q000379
650 12 Consumer Product Safety.|0https://id.nlm.nih.gov/mesh/
D003257
650 22 Drug Approval.|0https://id.nlm.nih.gov/mesh/D017277
650 22 Decision Making.|0https://id.nlm.nih.gov/mesh/D003657
650 22 United States Government Agencies.|0https://id.nlm.nih.gov
/mesh/D037041
651 7 United States.|2fast|0https://id.worldcat.org/fast/1204155
655 4 Electronic books.
655 7 Case studies.|2fast|0https://id.worldcat.org/fast/1423765
655 7 Technical reports.|2lcgft|0https://id.loc.gov/authorities/
genreForms/gf2015026093
655 7 Technical reports.|2fast|0https://id.worldcat.org/fast/
1941336
655 7 Case studies.|2lcgft|0https://id.loc.gov/authorities/
genreForms/gf2017026140
776 08 |iPrint version:|tRisk-characterization framework for
decision-making at the Food and Drug Administration.
|dWashington, D.C. : National Academies Press, ©2011
|z9780309212809|w(OCoLC)741786294
856 40 |uhttps://rider.idm.oclc.org/login?url=http://
search.ebscohost.com/login.aspx?direct=true&scope=site&
db=nlebk&AN=372484|zOnline eBook. Access restricted to
current Rider University students, faculty, and staff.
856 42 |3Instructions for reading/downloading this eBook|uhttp://
guides.rider.edu/ebooks/ebsco
901 MARCIVE 20231220
948 |d20160616|cEBSCO|tebscoebooksacademic|lridw
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