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Antimicrobial final monograph may blend FDA, industry approaches -- agency's Lumpkins.

This article was originally published in The Rose Sheet

Executive Summary

ANTIMICROBIAL PRODUCTS FINAL MONOGRAPH MAY BLEND FDA, INDUSTRY APPROACHES to the regulation of products that contain antimicrobial ingredients, FDA Division of OTC Drug Product's Debbie Lumpkins predicted at a June 2-3 symposium in Washington, D.C. on industry's Health Care Continuum Model. The regulatory review microbiologist forecast that the final reg would take a "blended approach" combining "some of the HCCM [and] some of the TFM." The symposium was sponsored jointly by the Cosmetic, Toiletry and Fragrance Association and the Soap and Detergent Association.



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