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OTC Antiseptic Wash Industry Disputes FDA Cost Estimate For Proposed 'Rub' Monograph

This article was originally published in The Tan Sheet

Executive Summary

FDA’s estimate for the economic impact of its proposal requiring additional safety and efficacy data for OTC antiseptic rub excludes the current benefit the products provide in fighting infection, says the American Cleaning Institute. Industry places annual cost over a 10-year-period at as much as $6.7m.


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