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Vulvovaginal Candidiasis: Developing Drugs for Treatment Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2019 Clinical/Antimicrobial Vulvovaginal Candidiasis: Developing Drugs for Treatment Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@ /drugs/guidance-compliance-regulatory-information/guidances-drugs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2019 Clinical/Antimicrobial TABLE OF CONTENTS I. INTRODUCTION 1 II. DEVELOPMENT PROGRAM 2 A. General Considerations 2 1. Drug Development Population 2 2. Efficacy Considerations 2 3. Safety Considerations 2 B. Specific Efficacy Trial Considerations 2 1. Clinical Trial Designs 2 2. Clinical Microbiology Considerations3 3. Enrollment Criteria 3 4. Randomization and Blinding 4 5. Specific Populations 4 6. Dose Selection 4 7. C