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Antimicrobials review

This article was originally published in The Rose Sheet

Executive Summary

FDA Anti-Infective Drugs Advisory Committee will discuss microbiologic endpoints as surrogates for clinical efficacy in clinical trials designed to address the safety and efficacy of antiseptic health care drug products May 11, the agency announces. Meeting will be held at the Holiday Inn in Gaithersburg, MD with an open public hearing held between 1 p.m.-2 p.m. 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 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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