FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Non-Prescription Drugs Advisory Committee

in Joint Session with the

Dermatologic and Ophthalmic Drugs Advisory Committee

May 6, 2004

AGENDA

8:00 a.m. Call to Order and Introductions Louis R. Cantilena, Jr., M.D., Ph.D.

Chair, Nonprescription Drugs Advisory Committee, NDAC

Conflict of Interest Statement LCDR Dornette Spell-LeSane, MHA, NP-C

Acting Executive Secretary, NDAC

Welcome and Introductory Comments Charles Ganley, M.D.

Director, Division of Over-The -Counter

Drug Products (DOTCDP), FDA

______________________________________________________________________________________

Efficacy and labeling issues for the over-the-counter drug products used in treatment of tinea pedis

in patients 12 years of age and over

8:15 FDA Presentation

Natural history of tinea pedis and Joseph Porres, M.D., Ph.D.

dermatophyte infections Medical Officer, DDDDP, FDA

Study design and efficacy results for Kathleen Fritsch, Ph.D.

tinea pedis clinical trials (Rx and OTC) Mathematical Statistician, Division of

Biometrics III, FDA

History and overview of OTC Topical Houda Mahayni, Ph.D.

Antifungal Drug Products Monograph Interdisciplinary Scientist, DOTCDP, FDA

Topical antifungal drug product labeling Daiva Shetty, M.D.

Medical Officer, DOTCDP, FDA

10:15 Break

Non-Prescription Drugs Advisory Committee

in Joint Session with the

Dermatologic and Ophthalmic Drugs Advisory Committee

May 6, 2004

AGENDA (Cont.)

10:30 FDA Presentation cont.

Infectious disease complications Alan Bisno, M.D.

of tinea pedis Professor Emeritus, University of Miami, School of Medicine

Microbiology and dermatophyte Mahmoud Ghannoum, M.Sc., Ph.D.

resistance related to the treatment of Director, Center for Medical Mycology and

tinea pedis Mycology Reference Laboratory &

Professor, Department of Dermatology,

University Hospitals of Cleveland and Case

Western Reserve University

11:30 Committee Discussions

12:00 Lunch

1:00 Open Public Hearing

2:30 Committee Discussions

3:00 Break

3:15 Committee Questions

5:30 Adjourn

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Non-Prescription Drugs Advisory Committee

in Joint Session with the

Dermatologic and Ophthalmic Drugs Advisory Committee

AGENDA

May 7, 2004

8:00 a.m. Call to Order and Introductions Louis R. Cantilena, Jr., M.D., Ph.D.

Chair, Nonprescription Drugs Advisory Committee, NDAC

Conflict of Interest Statement LCDR Dornette Spell-LeSane, MHA, NP-C

Acting Executive Secretary, NDAC

Charge to the Committee Jonathan Wilkin, M.D.

Director, Division of Dermatologic and

Dental Drug Products, FDA

_______________________________________________________________________________

Efficacy and labeling issues for the over-the-counter drug products

used in treatment of tinea pedis in patients 12 years of age and over

Meeting Continued from May 6, 2004

8:15 Committee Questions

10:45 Break

11:00 Open Public Hearing

12:00 Closed Session

Non-Prescription Drugs

Advisory Committee ACS Conference Room

Dermatologic and Opthalmic Drugs

Advisory Committee Parklawn Bldg, “Chesapeake” Conference Room

3:30 Adjourn