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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

 
Product
Telecon with Sponsor 2-16-2011 - concerns discussed and resolved
Revised container label needs to be submitted
 
Clinical
Biopsy study and SAE report of leukocytoclastic vasculitis
Inter-center consultation – update
Advisory committee
 
OBE/DE
Post-licensure registry study PMR proposal 
 
APLB
Labeling issues
Proprietary name review – Laviv
 
Administrative
Labeling meetings scheduled
 
Participants
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