A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration
National Academies Press (Verlag)
978-0-309-21280-9 (ISBN)
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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.
Table of Contents
Front Matter
A Risk-Characterization Framework for Decision-Making at the Food
and Drugh Administration
Summary
1 Introduction
2 A Risk-Characterization Framework
3 Case Study of a Mitigation-Selection Decision
4 Case Study of a Targeting Decision
5 Case Study of a Strategic-Investment Decision
6 Case Study of a Targeting Decision That Spans Food and Drug
Administration Centers
7 Conclusions and Future Directions
Appendix A: Letter Report on the Development of a Model for Ranking
FDA Product Categories on the Basis of Health Risks
Appendix B: Statement of Task for the Committee on Ranking FDA
Product Categories Based on Health Consequences, Phase II
Appendix 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
Appendix D: Biographic Information on the Committee on Ranking FDA
Product Categories Based on Health Consequences, Phase II
Appendix E: Factors Hypothesized as Important in Understanding Risk
1 Front Matter; 2 A Risk-Characterization Framework for Decision-Making at the Food and Drugh Administration; 3 Summary; 4 1 Introduction; 5 2 A Risk-Characterization Framework; 6 3 Case Study of a Mitigation-Selection Decision; 7 4 Case Study of a Targeting Decision; 8 5 Case Study of a Strategic-Investment Decision; 9 6 Case Study of a Targeting Decision That Spans Food and Drug Administration Centers; 10 7 Conclusions and Future Directions; 11 Appendix A: Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks; 12 Appendix B: Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II; 13 Appendix 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; 14 Appendix D: Biographic Information on the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II; 15 Appendix E: Factors Hypothesized as Important in Understanding Risk
Verlagsort | Washington |
---|---|
Sprache | englisch |
Maße | 152 x 229 mm |
Themenwelt | Medizin / Pharmazie ► Gesundheitsfachberufe ► Diätassistenz / Ernährungsberatung |
Sozialwissenschaften ► Politik / Verwaltung ► Staat / Verwaltung | |
ISBN-10 | 0-309-21280-4 / 0309212804 |
ISBN-13 | 978-0-309-21280-9 / 9780309212809 |
Zustand | Neuware |
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