Food and Drug Administration

Anti-Infective Drugs Advisory Committee

Pediatric Subcommittee

October 29, 2003


Atopic Dermatitis - Clinical Course and Therapeutic Options, Dr. Bindi Nikhar, MD FAAP, FDA (HTM) (PPT)

Hypothalamic-Pituitary-Adrenal Axis Suppression Following Topical Corticosteriod Administration, Dr. Jean Temeck, MD, FDA (HTM) (PPT)

Topical Corticosteriods and HPA Axis Suppression, Dr. Denise Cook, MD, FDA (HTM) (PPT)

Topical Corticosteriod Adverse Events in Pediatric Patients - Analysis of Postmarketing Reports, Dr. Claudia Karwoski, PharmD, FDA (HTM) (PPT)

Risk Management Programs - FDA Experience and Evolving Guidance on Risk Management Practices, Dr. Anne Trontell, MD, MPH, FDA (HTM) (PPT)

One Year Post Exclusivity Adverse Event Monitoring as Mandated by the Best Pharmaceuticals for Children Act, Dr. Solomon Iyasu and Dr. ShaAvhree Buckman, FDA (HTM) (PPT)

Draft Questions (HTM) (PPT)

Open Public Hearing

Presentation by Jerry Roth, Dermaceuticals, Inc. (HTM) (PPT)

Presentation by Dr. David Margolis, MD PhD, University of Pennsylvania School of Medicine (HTM) (PPT)