About: FDA preemption

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FDA preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding products approved by the Food and Drug Administration (FDA). It has been a highly-contentious issue. In general, consumer groups are against it, but the FDA and pharmaceutical manufacturers are in favor of it and argues that the FDA should set both the floor and the ceiling for drug regulation.

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  • FDA preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding products approved by the Food and Drug Administration (FDA). It has been a highly-contentious issue. In general, consumer groups are against it, but the FDA and pharmaceutical manufacturers are in favor of it and argues that the FDA should set both the floor and the ceiling for drug regulation. Michigan is the only state that voluntarily applies FDA preemption to its own state tort law through a regulatory compliance defense, but the law has been controversial and efforts to repeal it were underway in 2009. (en)
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  • August 2019 (en)
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  • FDA preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding products approved by the Food and Drug Administration (FDA). It has been a highly-contentious issue. In general, consumer groups are against it, but the FDA and pharmaceutical manufacturers are in favor of it and argues that the FDA should set both the floor and the ceiling for drug regulation. (en)
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  • FDA preemption (en)
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