Food and Drug Administration
September 29, 2005
Slides
Topic I
Norvartis
Exjade® (deferasirox; ICL670) Introduction, PK Narang, PhD, FCP (HTM) (PPT)
Iron Overload: Complications and Need for Therapy, John Porter, MD (HTM) (PPT)
Efficacy and Safety, Peter Marks, MD (HTM) (PPT)
Conclusions on Benefit and Risk, Elliott Vichinsky, MD (HTM) (PPT)
FDA
Presentation by George Shashaty, MD (HTM) (PPT)
Topic II
Site Visit Review of the Division of Hematology Laboratories, Hira Nakhasi, PhD (HTM) (PPT)
Division of Hematology, Basil Golding, MD (HTM) (PPT)
Site Visit Presentation, February 25, 2005, Basil Golding, MD (HTM) (PPT)
BPAC Site Visit Report Presentation (HTM) (PPT)
Laboratory of Plasma Derivatives Safety and Quality Control Section, Mei-ying Yu, PhD (HTM) (PPT)
LH/Q3012R Molecular Biology, Immunology, & Genetics of Coagulation Factors, Jay Lozier, MD, PhD (HTM) (PPT)
Open Public Hearing
Presentation by Lynn Amer (PDF)
Petition Re: NDA for Exjade (PDF)