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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bioresearch Monitoring Mid-Cycle Review, August 11, 2009 - Laviv

MEMORANDUM         DEPARTMENT OF HEALTH AND HUMAN  SERVICES

  Public Health Service
  Food and Drug Administration
  Center for Biologics Evaluation and Research
  _____________________________________________________________________

DATE         August 11, 2009
  
FROM         Janet White, Bioresearch Monitoring Branch, HFM-664
                Division of Inspections and Surveillance
                Office of Compliance and Biologics Quality

THROUGH     Patricia  Holobaugh, Bioresearch Monitoring Branch Chief, HFM-664 

TO             John Thomas, HFM-730, Chair, BLA Committee
                Lori  Tull, HFM-705, RPM, BLA Committee           
  
SUBJECT      Bioresearch Monitoring Mid-Cycle Review
               BLA: STN 125348/0
               Sponsor: Isolagen Technologies, Inc.
               Product: Autologous Human Fibroblasts  (Isolagen Therapy™) 

     
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  Janet K.  White
Consumer Safety  Officer