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In Brief: OTC label reform

This article was originally published in The Tan Sheet

Executive Summary

OTC label reform: Internal FDA committee on OTC label reform met for the first time during the week of June 11 to discuss how to proceed toward a regulatory proposal on OTC label reform. In a June 9 "Talk Paper," FDA noted the increasing acceptance of consumer friendly labeling by the OTC industry and said that "the agency is encouraging this trend and expects in the future to publish a proposal for a new, more useful OTC drug label in the Federal Register." In addition to its use by J&J/Merck's Pepcid AC and SmithKline Beecham's Tagamet HB, the new labeling format also is being adopted by manufacturers of non-switch OTCs. Thompson Medical plans to have its full line of OTCs in consumer friendly labeling by the end of 1995 ("The Tan Sheet" May 22, In Brief)..
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