A risk-characterization framework for decision-making at the Food and Drug Administration:
Saved in:
| Corporate Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Washington D.C.
National Academies Press
[2011]
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| Subjects: | |
| Online Access: | FAW01 FAW02 Volltext |
| Item Description: | Title from PDF t.p Description based on version viewed October 3, 2014 |
| Physical Description: | 1 online resource (1 PDF file (xiv, 192 pages)) illustrations |
| ISBN: | 0309212804 0309212812 1283135167 9780309212809 9780309212816 9781283135160 |
Staff View
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| 505 | 8 | |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 | |
| 505 | 8 | 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 -- |t Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks -- |t Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- |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 -- |t Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II -- |t Factors Hypothesized as Important in Understanding Risk |
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| contents | 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 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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| format | Electronic eBook |
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| spelling | National Academies (U.S.) Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II Verfasser aut 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 txt rdacontent c rdamedia cr rdacarrier Title from PDF t.p Description based on version viewed October 3, 2014 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 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 United States / Food and Drug Administration / Management United States / Food and Drug Administration fast United States Food and Drug Administration Case studies Consumer Product Safety Risk Assessment / methods Decision Making Drug Approval United States Government Agencies POLITICAL SCIENCE / Government / State & Provincial bisacsh Management fast Public health fast Decision making United States Case studies Product safety United States Decision making Case studies Risk assessment United States Case studies USA (DE-588)4522595-3 Fallstudiensammlung gnd-content Erscheint auch als Druck-Ausgabe Risk-characterization framework for decision-making at the Food and Drug Administration http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=372484 Aggregator Volltext |
| spellingShingle | 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 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 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 United States / Food and Drug Administration / Management United States / Food and Drug Administration fast United States Food and Drug Administration Case studies Consumer Product Safety Risk Assessment / methods Decision Making Drug Approval United States Government Agencies POLITICAL SCIENCE / Government / State & Provincial bisacsh Management fast Public health fast Decision making United States Case studies Product safety United States Decision making Case studies Risk assessment United States Case studies |
| subject_GND | (DE-588)4522595-3 |
| 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 | a risk characterization framework for decision making at the food and drug administration |
| topic | United States / Food and Drug Administration United States / Food and Drug Administration / Management United States / Food and Drug Administration fast United States Food and Drug Administration Case studies Consumer Product Safety Risk Assessment / methods Decision Making Drug Approval United States Government Agencies POLITICAL SCIENCE / Government / State & Provincial bisacsh Management fast Public health fast Decision making United States Case studies Product safety United States Decision making Case studies Risk assessment United States Case studies |
| topic_facet | United States / Food and Drug Administration United States / Food and Drug Administration / Management United States Food and Drug Administration Case studies Consumer Product Safety Risk Assessment / methods Decision Making Drug Approval United States Government Agencies POLITICAL SCIENCE / Government / State & Provincial Management Public health Decision making United States Case studies Product safety United States Decision making Case studies Risk assessment United States Case studies USA Fallstudiensammlung |
| url | http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=372484 |
| work_keys_str_mv | AT nationalacademiesuscommitteeonrankingfdaproductcategoriesbasedonhealthconsequencesphaseii ariskcharacterizationframeworkfordecisionmakingatthefoodanddrugadministration |