Food and Drug Administration

Nonprescription Drugs Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee

May 6, 2004


Tinea Pedis Natural History & Clinical Trials, Dr. Joseph Porres, MD, PhD (HTM) (PPT)

Study Design and Efficacy Results for Tinea Pedis Clinical Trials, Dr. Kathleen Fritsch, PhD, FDA (HTM) (PPT)

History and Overview of OTC Topical Antifungal Drug Products, Dr. Houda Mahayni, RPh, PhD, FDA (HTM) (PPT)

Topical Antifungals for T. Pedis Labeling Issues, Dr. Daiva Shetty, MD, FDA (HTM) (PPT)

Tinea Pedis and Cellulitis of the Lower Extemities, Dr. Alan Bisno, MD, FACP, University of Miami School of Medicine (HTM) (PPT)

Microbiology and Dermatolophyte Resistance Related to the Treatment of Tinea Pedis, Dr. M. Ghannoum, PhD, University Hospitals of Cleveland (HTM) (PPT)

Committee Discussion (HTM) (PPT)

Open Public Hearing

CHPA Comments on Efficacy and Labeling Issues for OTC Drug Products Used in the Treatment of Tinea Pedis, Dr. Doug Bierer, PhD and Dr. Boni Elewski, MD (HTM) (PPT)

Over-The-Counter Antifungal Drug Products Treatment of Tinea pedu, Schering-Plough HealthCare Products (HTM) (PPT)

Perspectives on Enhancing Consumer Outcomes With Topical Antifungals, Novartis (HTM) (PPT)