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Home » FDA Publishes Draft Guidance on Vulvovaginal Candidiasis Drug Development
FDA Publishes Draft Guidance on Vulvovaginal Candidiasis Drug Development
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Drugmakers developing treatments for uncomplicated vulvovaginal candidiasis should conduct two adequate and well-controlled clinical trials with a superiority design to demonstrate efficacy, the FDA recommends.
In draft guidance, the agency suggested that these trials be randomized, double-blinded and either placebo-controlled or active-controlled.
Specimens collected for microbiologic evaluation should specifically be examined for yeast and tested for susceptibility to appropriate antifungal drugs, the FDA recommends.
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