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FDA enforcement would be "severely" hindered by GOP risk assessment regs -- FDAer.

This article was originally published in The Tan Sheet

Executive Summary

FDA ENFORCEMENT WOULD BE "SEVERELY" HINDERED BY PROPOSED GOP REGS by imposing formal risk assessment requirements to what are currently informal decisions, new FDA Deputy Commissioner for Policy William Schultz warned at a Feb. 2 hearing on Title III of the "Job Creation and Wage Enhancement Act" (HR 9). The risk assessment regulations would "severely impede" the agency's ability to initiate enforcement actions for drugs, medical devices and other products, he stated. The hearing was held jointly by the House Commerce/health subcommittee and the commerce and trade subcommittee.

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