A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011) / Chapter Skim
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Appendix B: Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II
Appendix B: Statement of Task for the Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II
Pages 177-178
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From page 177... ...
The committee will consult with FDA to finalize products and/or product categories that are within FDA mandates for human and veterinary drugs, biologics, medical devices, foods, cosmetics, and products that emit radiation. The committee will continue to review selected scientific literature and consult with FDA to determine adverse and beneficial health consequences related to the selected products and/or product categories.
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From page 178... ...
In assessing health consequences, consider both the risks and the beneficial aspects of product use, and where applicable and feasible, consider the potential impact on population health if beneficial product use is curtailed through risk reduction strategies. In reviewing selected scientific literature, the committee shall consider the scientific literature broadly, to include, as appropriate, social science and economic literature, grey literature, and regulatory policy literature.
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