| Description |
1 online resource (1 PDF file (xiv, 192 pages)) : illustrations |
|
text file |
| Note |
Title from PDF title page. |
| Bibliography |
Includes bibliographical references. |
| 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 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. |
| Funding |
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. |
| 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. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
United States. Food and Drug Administration -- Case studies.
|
|
United States. Food and Drug Administration. |
| Genre/Form |
Case studies.
|
| Subject |
United States. Food and Drug Administration.
|
|
United States. Food and Drug Administration -- Management. |
|
Decision making -- United States -- Case studies.
|
|
Decision making. |
|
United States. |
|
Product safety -- United States -- Decision making -- Case studies.
|
|
Product safety. |
|
Risk assessment -- United States -- Case studies.
|
|
Risk assessment. |
|
Risk Assessment -- methods. |
|
Consumer Product Safety. |
|
Drug Approval. |
|
Decision Making. |
|
United States Government Agencies. |
| Genre/Form |
Electronic books.
|
|
Technical reports.
|
|
Technical reports.
|
|
Case studies.
|
| Other Form: |
Print version: Risk-characterization framework for decision-making at the Food and Drug Administration. Washington, D.C. : National Academies Press, ©2011 9780309212809 (OCoLC)741786294 |
| ISBN |
9780309212816 |
|
0309212812 |
|
1283135167 |
|
9781283135160 |
|
9780309212809 |
|
0309212804 |
|
