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Proposed OTC labeling changes would cost $155 mil. -- preliminary NDMA data.

This article was originally published in The Tan Sheet

Executive Summary

PROPOSED OTC LABELING CHANGES WOULD COST INDUSTRY $155 MIL. if implemented over two years, according to preliminary data from an April survey of Nonprescription Drug Manufacturers Association members. Procter & Gamble Regulatory Affairs Section Head William Kozarek, PhD, told FDA at a May 8 OTC "feedback" meeting in Rockville, Md. that the agency's proposed labeling changes for branded and private label OTC products (excluding packaging), would cost industry $129 mil. and $26 mil., respectively, allowing for a two-year implementation period. FDA estimated in its Feb. 27 proposed OTC uniform labeling rule that the changes would cost $14.2 mil. ("The Tan Sheet" March 3, pp. 1-9).





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