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In Brief: FDA OTC adverse reaction reporting

This article was originally published in The Rose Sheet

Executive Summary

FDA OTC adverse reaction reporting: Proposal expected out in early 1998 along with the final action on the poison ivy indication in the skin protectant monograph, according to FDA's semi-annual regulatory agenda. The agency also lists July 1998 as the target date for release of a final rule on standard OTC labeling. The regulatory agenda, published in the Oct. 29 Federal Register, is issued four times a year, with estimated timetables of regulatory activities...



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