1/24/2008

An FDA proposal to restrict the addition of warnings to product labels would further delay informing the public about the potential dangers of drugs or medical devices, a group of House and Senate Democrats said in a letter to Commissioner Andrew von Eschenbach. "It is apparently designed to bolster the argument by companies defending against lawsuits that the regulations precluded them from adding contraindications, warnings, precautions and adverse reactions in the absence of FDA approval," the lawmakers stated.

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