Industry Cost Estimates For Proposed Antibacterials Rule Dwarf FDA’s
This article was originally published in The Rose Sheet
Executive Summary
In comments to FDA, the Personal Care Products Council and American Cleaning Institute challenge agency cost projections and question the need for clinical study data to back the efficacy of antibacterial hand-wash products, as called for in a proposed rule issued by the agency in December 2013. Groups say manufacturers require guidance and request an extension of the deadline for data submissions, current set for December 2014.