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Vaginal candidiasis clinical trials should use seven-day product control -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

VAGINAL CANDIDIASIS CLINICAL TRIALS SHOULD USE SEVEN-DAY THERAPY CONTROL, FDA recommends in a draft guidance on evaluating clinical studies of antimicrobials. FDA's Division of Anti-Infective Drug Products recommends that "two statistically adequate and well-controlled multi-center trials establishing equivalence or superiority to an approved product (seven-day regimen that is approved for Rx or OTC)" be conducted, the draft states.

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