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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
OODP/CDER/FDA
|
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
OODP/OND/CDER
|
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)
|
|
Questions
(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,
OND, CDER, FDA |
Questions
to the Committee
(ppt) (htm)
|
|
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