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GUIDANCE DOCUMENT

Vulvovaginal Candidiasis: Developing Drugs for Treatment August 2019

Download the Final Guidance Document Read the Federal Register Notice
Final
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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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