Home » FDA Publishes Draft Guidance on Vulvovaginal Candidiasis Drug Development
FDA Publishes Draft Guidance on Vulvovaginal Candidiasis Drug Development
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In draft guidance, the agency suggested that these trials be randomized, double-blinded and either placebo-controlled or active-controlled.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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