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FDA semi-annual agenda

This article was originally published in The Rose Sheet

Executive Summary

A notice of proposed rulemaking for topical antimicrobial consumer products and healthcare antiseptics is slated for release in March, according to FDA's semi-annual agenda, published in Oct. 31 Federal Register. Agency is working to finalize a tentative final monograph for topical antimicrobials published in the June 1994 Federal Register. In October, the Nonprescription Drugs Advisory Committee met to address questions regarding the safety and efficacy of consumer antimicrobials (1"The Rose Sheet" Oct. 24, 2005, p. 9). Additional items on the semi-annual agenda include an amendment to the NPRM for OTC dandruff, seborrheic dermatitis and psoriasis products in December and technical amendments to the final action for skin protectant products marketed as lip protectants in December. The agency expects to release an NPRM for skin bleaching products in March and final action for plaque gingivitis products is slated for October of next year...

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