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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Fibrocell BLA 125348 Review Team Meeting, Feburary 23, 2011 - Laviv

Review updates

Telecon with Sponsor 2-16-2011 - concerns discussed and resolved
Revised container label needs to be submitted
Biopsy study and SAE report of leukocytoclastic vasculitis
Inter-center consultation – update
Advisory committee
Post-licensure registry study PMR proposal 
Labeling issues
Proprietary name review – Laviv
Labeling meetings scheduled
Celia Witten                 Kimberly Benton
Stephanie Simek           Keith Wonnacott
Wilson Bryan                Lori Tull
Randa Melhem              Patrick Riggins
Gang Wang                  Shiowjen Lee
Janet White
Craig Zinderman
Yao-Yao Zhu
Agnes Lim
Bruce Schneider
Mark Borgini
John Thomas
Donald Fink