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FDA antimicrobials review

This article was originally published in The Rose Sheet

Executive Summary

May 11 meeting of the Anti-Infective Drugs Advisory Committee is cancelled. The committee was to discuss microbiologic endpoints as surrogates for efficacy in clinical trials designed to address the safety and efficacy of antiseptic health care drug products, which could impact OTC antimicrobials. Cosmetic, Toiletry and Fragrance Association and Soap and Detergent Association have urged the agency to use their proposed test methods to evaluate efficacy of finished topical antimicrobials in the OTC Antiseptic Health Care Final Monograph...



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