Tysabri ® (natalizumab) Biogen Idec Inc. BLA 125104 /15. Peripheral and Central Nervous System Drugs Advisory Committee Gaithersburg, Maryland March 7-8, 2006 Alice Hughes, M.D. Division of Neurology Products. Center for Drug Evaluation and Research. Review of Non-PML Safety Issues.
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Peripheral and Central Nervous System
Drugs Advisory Committee
March 7-8, 2006
Alice Hughes, M.D.
Division of Neurology Products
Center for Drug Evaluation and Research
Tysabri Review Team
Regulatory Project Manager (DNP)Product (DMA)
Katherine Needleman, M.S., RAC Elena Gubina, Ph.D.
Chana Fuchs, Ph.D. Team Leader
Susan McDermott, M.D. Pharm/Tox (DNP)
Alice Hughes, M.D.Barbara Wilcox, Ph.D.
Wilson Bryan, M.D., Team Leader Lois Freed, Ph.D., Team Leader
Marc Walton, M.D., Ph.D., Deputy Director
Russell Katz, M.D., Director Labeling (DDMAC)
Catherine Gray, Pharm.D.
Clinical Pharmacology (OCBP)
Iftekhar Mahmood, Ph.D. RiskMAP Review Team (ODS)
Hong Zhao, Ph.D., Team Leader
Sharon Yan, Ph.D.
Kun Jin, Ph.D., Team Leader