FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

 

Nonprescription Drugs and Dermatologic and Ophthalmic Drugs

Advisory Committee Meeting

May 6, 2004

 

DRAFT 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, FDA

OR

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

 

8:15 FDA Presentation

 

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

dermatophyte infections Medical Officer, Division of Dermatologic

and Dental Drug Products, FDA

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

 

9:45 Committee Discussion

 

10:15 Break

 

10:30 FDA Presentation cont.

 

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, Division of Over-

The-Counter Drug Products, FDA

 

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

Medical Officer, Division of Over-The

Counter Drug Products, FDA

 

11:30 Committee Discussion

 

12:00 Lunch

 

1:00 Open Public Hearing

 

2:05 Committee Discussions

 

3:00 Break

 

3:15 Committee Questions

 

5:30 Adjourn


FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

 

Nonprescription Drugs and Dermatologic and Ophthalmic Drugs

Advisory Committee Meeting

May 7, 2004

 

DRAFT 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

 

Charge to the Committee Charles Ganley, M.D.

Director, Division of Over-The -Counter

Drug Products, FDA

OR

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

Cont.

 

8:15 Committee Questions

 

10:45 Break

 

11:00 Open Public Hearing

 

12:00 Closed Session

 

Division of Over-The -Counter ACS Conference Room

Drug Products, FDA

 

Division of Dermatologic and Parklawn Bldg Conference Room C

Dental Drug Products, FDA

 

3:30 Adjourn