A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011) / Chapter Skim
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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 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
Pages 179-184
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From page 179... ...
Today, FDA uses best available data and information on public health risks and benefits to inform the public health component of these decisions. The agency is asking the NAS to suggest approaches to assessing health consequences in a way that allows public health impacts to be compared within and across broad program areas, and to identify information needs for addressing key uncertainties.
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From page 180... ...
Loss of public confidence in these products and any resulting reduction in inoculation rates represents a potentially serious public health hazard. What measures of public health impacts should be taken into account in making decisions about safety interventions and/or risk management strategies, and setting priorities for action?
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From page 181... ...
There are insufficient resources to cover more than 10 sites. How can FDA incorporate public health impacts into its decisions about trial inspection priorities and risk management strategies in this scenario?
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From page 182... ...
As a consequence, FDA staff frequently perform ongoing risk assessments to inform actions and help to define data collection needs, safety interventions and/or risk management strategies. What measures of public health risks and benefits should be taken into account in making decisions about safety interventions and/or risk management strategies, and setting priorities for action?
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From page 183... ...
There are communications about emerging high risk issues, chronic risk areas and general safety information. What risk factors should be taken into account in setting priorities for which web pages should be updated or created first, to address the most pressing public health issues?
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