A risk-characterization framework for decision-making at the Food and Drug Administration /:
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...
Gespeichert in:
| Körperschaft: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Washington D.C. :
National Academies Press,
[2011]
|
| Schriftenreihe: | Online access: National Academy of Sciences National Academies Press.
Online access: NCBI NCBI Bookshelf. |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | 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. |
| Beschreibung: | Title from PDF title page. |
| Beschreibung: | 1 online resource (1 PDF file (xiv, 192 pages)) : illustrations |
| Bibliographie: | Includes bibliographical references. |
| ISBN: | 9780309212816 0309212812 1283135167 9781283135160 |
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| 110 | 2 | |a National Academies (U.S.). |b Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, |e author. | |
| 245 | 1 | 2 | |a A risk-characterization framework for decision-making at the Food and Drug Administration / |c 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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| 500 | |a Title from PDF title page. | ||
| 504 | |a Includes bibliographical references. | ||
| 520 | 3 | |a 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 | |a 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 | |a Version viewed October 3, 2014. | |
| 505 | 0 | 0 | |t Introduction -- |t A Risk-Characterization Framework -- |t Case Study of a Mitigation-Selection Decision -- |t Case Study of a Targeting Decision -- |t Case Study of a Strategic-Investment Decision -- |t Case Study of a Targeting Decision That Spans Food and Drug Administration Centers -- |t Conclusions and Future Directions -- |g A: |t Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks -- |g B: |t Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- |g C: |t Scenarios Provided by the U.S. Food and Drug Administration to the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- |g D: |t Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- |g E: |t Factors Hypothesized as Important in Understanding Risk. |
| 610 | 1 | 0 | |a United States. |b Food and Drug Administration |v Case studies. |
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| 650 | 0 | |a Risk assessment |z United States |v Case studies. | |
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| 650 | 6 | |a Prise de décision |z États-Unis |v Études de cas. | |
| 650 | 6 | |a Produits commerciaux |x Sécurité |z États-Unis |x Prise de décision |v Études de cas. | |
| 650 | 6 | |a Évaluation du risque |z États-Unis |v Études de cas. | |
| 650 | 6 | |a Prise de décision. | |
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| 776 | 0 | 8 | |i Print version: |t Risk-characterization framework for decision-making at the Food and Drug Administration. |d Washington, D.C. : National Academies Press, ©2011 |z 9780309212809 |w (OCoLC)741786294 |
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| author_corporate | National Academies (U.S.). Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II |
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| author_facet | National Academies (U.S.). Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II |
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| 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 -- Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks -- Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- Scenarios Provided by the U.S. Food and Drug Administration to the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- Factors Hypothesized as Important in Understanding Risk. |
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| genre | Case studies fast |
| genre_facet | Case studies |
| geographic | United States fast |
| geographic_facet | United States |
| id | ZDB-4-EBA-ocn741650502 |
| illustrated | Illustrated |
| indexdate | 2024-11-27T13:17:55Z |
| institution | BVB |
| isbn | 9780309212816 0309212812 1283135167 9781283135160 |
| language | English |
| lccn | 2011283692 |
| oclc_num | 741650502 |
| open_access_boolean | |
| owner | MAIN DE-863 DE-BY-FWS |
| owner_facet | MAIN DE-863 DE-BY-FWS |
| physical | 1 online resource (1 PDF file (xiv, 192 pages)) : illustrations |
| psigel | ZDB-4-EBA |
| publishDate | 2011 |
| publishDateSearch | 2011 |
| publishDateSort | 2011 |
| publisher | National Academies Press, |
| record_format | marc |
| series | Online access: National Academy of Sciences National Academies Press. Online access: NCBI NCBI Bookshelf. |
| spelling | National Academies (U.S.). Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II, author. 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. Washington D.C. : National Academies Press, [2011] 1 online resource (1 PDF file (xiv, 192 pages)) : illustrations text txt rdacontent computer c rdamedia online resource cr rdacarrier Title from PDF title page. Includes bibliographical references. 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. 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. Version viewed October 3, 2014. 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. United States. Food and Drug Administration Case studies. United States. Food and Drug Administration. United States. Food and Drug Administration fast Decision making United States Case studies. Product safety United States Decision making Case studies. Risk assessment United States Case studies. Decision making. http://id.loc.gov/authorities/subjects/sh85036199 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. aat POLITICAL SCIENCE Government State & Provincial. bisacsh Decision making fast Risk assessment fast United States fast Case studies fast has work: A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (Text) https://id.oclc.org/worldcat/entity/E39PCXyk9M98pkpF98gRGR76H3 https://id.oclc.org/worldcat/ontology/hasWork Print version: Risk-characterization framework for decision-making at the Food and Drug Administration. Washington, D.C. : National Academies Press, ©2011 9780309212809 (OCoLC)741786294 Online access: National Academy of Sciences National Academies Press. Online access: NCBI NCBI Bookshelf. FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=372484 Volltext |
| spellingShingle | A risk-characterization framework for decision-making at the Food and Drug Administration / Online access: National Academy of Sciences National Academies Press. Online access: NCBI NCBI Bookshelf. 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 -- Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks -- Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- Scenarios Provided by the U.S. Food and Drug Administration to the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- Factors Hypothesized as Important in Understanding Risk. United States. Food and Drug Administration Case studies. United States. Food and Drug Administration. United States. Food and Drug Administration fast Decision making United States Case studies. Product safety United States Decision making Case studies. Risk assessment United States Case studies. Decision making. http://id.loc.gov/authorities/subjects/sh85036199 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. aat POLITICAL SCIENCE Government State & Provincial. bisacsh Decision making fast Risk assessment fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh85036199 |
| title | A risk-characterization framework for decision-making at the Food and Drug Administration / |
| title_alt | 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 -- Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks -- Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- Scenarios Provided by the U.S. Food and Drug Administration to the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- Factors Hypothesized as Important in Understanding Risk. |
| title_auth | A risk-characterization framework for decision-making at the Food and Drug Administration / |
| title_exact_search | A risk-characterization framework for decision-making at the Food and Drug Administration / |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | A risk-characterization framework for decision-making at the Food and Drug Administration / |
| title_sort | risk characterization framework for decision making at the food and drug administration |
| topic | United States. Food and Drug Administration Case studies. United States. Food and Drug Administration. United States. Food and Drug Administration fast Decision making United States Case studies. Product safety United States Decision making Case studies. Risk assessment United States Case studies. Decision making. http://id.loc.gov/authorities/subjects/sh85036199 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. aat POLITICAL SCIENCE Government State & Provincial. bisacsh Decision making fast Risk assessment fast |
| topic_facet | 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 |
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