Pediatric Oncology Subcommittee

of the    

Oncologic Drugs Advisory Committee

March 14, 2006

Slides Presented at Meeting

Session I

Welcome and Introductory Comments

Karen Weiss, M.D.,  Deputy Director,

Office of Oncology Drug Products

OODP/CDER/FDA

Daunomycin: Pharmacokinetics in Children

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Stacy Berg, M.D.

Texas Children’s Cancer Center

Baylor College of Medicine

Questions to the Committee

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High Dose MTX

Toxicity & Safety

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Neurotoxicities in Children Treated for Acute Lymphoblastic Leukemia Using High Dose Methotrexate

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Malcolm Smith, M.D. ,Ph.D.

Associate Branch Chief, Pediatrics

Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI), NIH

&

Daniel Armstrong, M.D.

University of Miami School of Medicine

Questions to the Committee

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Session II

Review of Exjade Approval

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George Shashaty, M.D., Medical Officer

Division of Medical Imaging and Hematology Products

OODP/OND/CDER

Sponsor Presentation

Post Marketing Commitments with

Exjade (NDA 21-882)  

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Novartis Pharmaceuticals Corporation

Renaud Capdeville, M.D., Deputy Head Phase II/III Group

Clinical Oncology

Open Public Hearing

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Questions

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Session III

An Industry Perspective: Drug Shortages in Pediatric Oncology

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Wayne Rackoff, M.D.

Johnson & Johnson Pharmaceutical Research & Development , L.L.C.

CDER Drug Shortages Program

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Mark J. Goldberger, M.D. , M.P.H.

Drug Shortage Coordinator, CDER, FDA

Director, Office of Antimicrobial Products,

OND, CDER, FDA

Questions to the Committee

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