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Food and Drug Administration

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



Daunomycin: Pharmacokinetics in Children

(ppt) (htm)

Stacy Berg, M.D.

Texas Children’s Cancer Center

Baylor College of Medicine


Questions to the Committee

(ppt) (htm)



High Dose MTX

Toxicity & Safety

(ppt) (htm)


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

(ppt) (htm)


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

(ppt) (htm)




Session II


Review of Exjade Approval

(ppt) (htm)

George Shashaty, M.D., Medical Officer

Division of Medical Imaging and Hematology Products



Sponsor Presentation

Post Marketing Commitments with

Exjade (NDA 21-882)  

(ppt) (htm)


Novartis Pharmaceuticals Corporation

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

Clinical Oncology


Open Public Hearing

(ppt) (htm)




(ppt) (htm)


Session III


An Industry Perspective: Drug Shortages in Pediatric Oncology

(ppt) (htm)


Wayne Rackoff, M.D.

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

CDER Drug Shortages Program

(ppt) (htm)


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

Drug Shortage Coordinator, CDER, FDA

Director, Office of Antimicrobial Products,


Questions to the Committee

(ppt) (htm)




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