Reg reform bill's risk assessment exemption provisions called inadequate by FDA.Page 8
This article was originally published in The Rose Sheet
FDA CALLS S 343 RISK ASSESSMENT EXEMPTION FOR HEALTH THREATS "INADEQUATE" to "permit the agency to take expeditious action to avert harm." In an analysis of a revised version of the "Comprehensive Regulatory Reform Act" supported by Senate Majority Leader Robert Dole (R-KS) and Sen. Bennett Johnston (D-LA), FDA asserted that the exemption from conducting risk assessments for "likely health and safety threats" would not allow timely FDA actions.
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