Nonprescription Drugs Advisory Committee (NDAC)

in joint session with the

Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC)


March 24, 2005


Slides Presented


The committees will consider the safety considerations related to the switch of

dermatologic corticosteroids from prescription to over-the-counter (OTC) use.


Introduction                                                                  Charles Ganley, M.D., Division Director

[HTML]  [PPT]                                                          Division of Over-the-Counter Drug Products


FDA Presentations


OTC Dermatologic Topical                                           Mike Koenig, Ph.D., Interdisciplinary Scientist

Corticosteroids                                                             Division of Over-the-Counter Drug Products



Rx Topical Corticosteroids:                                           Denise Cook, M.D., Medical Officer

HPA Axis Suppression and                                           Division of Dermatologic and Dental Drug ProductsCutaneous Effects                          



Lessons Learned From Growth                                     Stephen Wilson, Dr. P.H., CAPT USPHS

Studies with Orally Inhaled and                                     Division of Biometrics II

Intranasal Corticosteroids



HPA Axis Suppression Studies:                                    Markham Luke, M.D., Medical Team Leader

Conduct, Utility, and Pediatric                                       Division of Dermatologic and Dental Drug Products




Open Public Hearing Speakers


Jerry Roth   [HTML]  [PPT]

Hill Dermaceuticals, Inc .


Michael D. Paranzino

Psoriasis Now


Charles N. Ellis, M.D.   [HTML]  [PPT]

University of Michigan Medical School


Valentine Ellis, MBA   [HTML]  [PPT]



Sandra Reed


Luz Fonacier