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GUIDANCE DOCUMENT

Vulvovaginal Candidiasis: Developing Drugs for Treatment June 2016

Draft

Not for implementation. Contains non-binding recommendations.

Vulvovaginal Candidiasis: Developing Drugs for Treatment

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 the treatment of vulvovaginal candidiasis (VVC). This draft guidance is intended to serve as a focus for continued discussions among the Division of Anti-Infective Products, pharmaceutical sponsors, the academic community, and the public.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.