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