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Antimicrobials review

This article was originally published in The Tan Sheet

Executive Summary

FDA Anti-Infective Drugs Advisory Committee will discuss microbiologic endpoints as surrogates for efficacy in clinical trials designed to address the safety and efficacy of antiseptic health care drug products, the agency announces. Meeting will be held May 11 at the Holiday Inn in Gaithersburg, Md. Those wishing to make a formal presentation should contact Tara Turner at 1turnert@cder.fda.gov, FDA says. Trials could impact OTC antimicrobials. The Cosmetic, Toiletry & Fragrance Association and Soap & 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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