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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bioresearch Monitor Filing Memo, December 7, 2010 - Bivigam

DATE:          December 07, 2010

FROM:         Lillian Ortega, Bioresearch Monitoring, HFM-664
                    Division of Inspections and Surveillance
                    Office of Compliance and Biologics Quality
                   Telephone: 301-827-6335            Fax: 301-827-6748
 
SUBJECT:    Bioresearch Monitoring Filing Memo
                    BLA/STN: 125389/0           Sponsor: Biotest Pharmaceuticals Corporation
 
TO:              Pratibha Rana                   HFM-380
                   Michael Kennedy               HFM-345
                   Mitchell Frost                              HFM-392
                   
Based upon my initial review of the clinical data contained within this electronic submission, the submission appears fileable.
 
 
 
/s/ 
_____________________
Lillian Ortega
Consumer Safety Officer
 
 
 
Cc:    
HFM-664 AccessChron
         
Draft: Ortega: 12/07/2010
Reviewed: Holobaugh