Docket Number:
FDA-2016-D-1662
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the overall clinical development program and clinical trial designs to support drugs for treating vulvovaginal candidiasis (VVC).

In general, this guidance focuses only on treating VVC. This guidance does not discuss clinical development programs focused on preventing or reducing the recurrence of VVC. Sponsors should discuss the clinical development of such programs with FDA.

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All written comments should be identified with this document's docket number: FDA-2016-D-1662.