Risk-Characterization Framework For Decision-Making At The Food And Drug Administration
Committee on Ranking FDA Product Categories Based on Health Consequences Phase II
ISBN 10: 0309212804 ISBN 13: 9780309212809
Published by National Academies Press, 2011
New
Soft cover
From
Basi6 International, Irving, TX, U.S.A.
Seller rating 5 out of 5 stars
AbeBooks Seller since June 24, 2016
This specific item is no longer available.
About this Item
Description:
New. US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service. Seller Inventory # ABEOCT25-71323
Synopsis:
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.
"About this title" may belong to another edition of this title.
Bibliographic Details
Title: Risk-Characterization Framework For ...
Publisher: National Academies Press
Publication Date: 2011
Binding: Soft cover
Condition: Brand New