Nonprescription
Drugs Advisory Committee (NDAC)
in joint session with the
Dermatologic
and Ophthalmic Drugs Advisory Committee (DODAC)
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:
Conduct, Utility, and Pediatric Division of Dermatologic and Dental Drug Products
Considerations
Open Public Hearing Speakers
Hill
Dermaceuticals, Inc .
Michael D. Paranzino
Psoriasis Now
Charles N. Ellis, M.D. [HTML] [PPT]
University of
Valentine Ellis,
MBA [HTML] [PPT]
GlaxoSmithKline
Sandra Reed
Luz Fonacier