Food and Drug Administration

Pediatric Advisory Committee

February 15, 2005


Possible Risk of Cancer From the Use of the Topical Immunosuppressants: Protopic and Elidel (tacrolimus and pimecrolimus), Dr. Dianne Murphy, FDA (HTM) (PPT)

Assessing Cancer Risk & Assuring Safe Use of Topical Immunosuppressants: Recent History, Dr. Susan Cummins, MD, MPH, FDA (PDF) (PPT)

Epstein-Barr Virus: Cancer and Immunosuppression, Jeffrey Cohoen, NIH (HTM) (PPT)

FDA Perspective Topical Immunosuppressants, Dr. Bindi Nikhar, MD, FDA (HTM) (PPT)

Systemic Human Exposure of Pimecrolimus and Tacrolimus Following Topical Application, Dr. Tapash Ghosh, PhD, FDA (HTM) (PPT)

Topical Immunosuppressants (Calcineurin Inhibitors) - Animal Toxicology, Dr. Barbara Hill, PhD, FDA (HTM) (PPT)

Post-Marketing Cases of Tumors Reported with the Topical Immunosuppressants (Calcineurin Inhibitors), Dr. Marilyn Pitts, PharmD, FDA (HTM) (PPT)

Considerations for the Use of Risk Minimization Action Plans - FDA Draft Guidance and Experience, Dr. Anne Trontell, MD, MPH, FDA (HTM) (PPT)

Overview of Prescription Drug Promotion, Melissa Moncavage, FDA (HTM) (PPT)

Questions to Committee about Potential Cancer Risk with Use of Topical Immunosuppressants (Calcineurin Inhibitors) (HTM) (PPT)

Wrap Up Comments, Dr. Jonathan Wilkin, MD (HTM) (PPT)


ELIDEL® (pimecrolimus) Cream 1% - Introduction, Dr. Mathias Hukkelhoven, PhD, Novartis Pharmaceuticals Corp. (HTM) (PPT)

ELIDEL® (pimecrolimus) Cream 1% Safety Update Feb, 2005, Dr/ Thomas Hultsch, MD, Novartis Pharmaceuticals Corp. (PDF) (PPT)

Atopic Dermatitis: Disease Impact and Therapy, Dr. Lawrence Eichenfield, MD, University of California (HTM) (PPT)

Supportive Slides, Novartis Pharmaceuticals Corp. (HTM) (PPT)

Protopic® (tacrolimus) Ointment, Dr. Amy Paller, MD and Dr. M Rico, MD, Fujisawa Healthcare, Inc. (HTM) (PPT)

Open Public Hearing

Written statement by Dr. Daniel Yarosh, PhD, Applied Genetics, Inc., New York (PDF)

Presentation by Dr. Daniel Yarosh, PhD, Applied Genetics, Inc., New York (HTM) (PDF) (PPT)

Written statement by LaDonna Williams (PDF)

Written statememt by Ruthann Newton, Inflammatory Skin Disease Institute (PDF)

Presentation by Dr. Vincent Beltrani, MD, FAAAAI, Columbia University, NY (HTM) (PDF) (PPT)

Written statement by TSunetoshi Shimazu (PDF)

Written statement by TSunetoshi Shimazu (PDF)

Abstract Preview by TSunetoshi Shimazu (PDF)

Letter by Dr. Rokuro Hama, MD (PDF)

Presentation by Dr. Rokuro Hama, MD (HTM) (PDF) (PPT)