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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bioresearch Monitoring Mid-Cycle Review Memo, March 15, 2011 - Bivigam

 

DATE:          March 15, 2011
 
FROM:         Lillian Ortega, Bioresearch Monitoring, HFM-664
                    Division of Inspections and Surveillance
                   Office of Compliance and Biologics Quality
 
THROUGH:    Pat Holobaugh, Bioresearch Monitoring Branch Chief, HFM-664
 
TO:              Michael Kennedy, HFM- 345, Chair person, BLA Committee
                    Mitchell Frost, HFM-392, Clinical Reviewer, BLA Committee
                    Pratibha Rana, HFM-380, RPM, BLA Committee
 
SUBJECT:    Bioresearch Monitoring Mid-Cycle Review
                    BLA/STN: 125389/0
Sponsor:       Biotest Pharmaceuticals Corporation
                    Product: Immune Globulin Intravenous (Human) 10% (Nabi- IGIV)
 
Bioresearch Monitoring clinical investigator inspection assignments were issued on December 20, 2010 for the following study sites:
 

Site
Study Site
Location
Subjects
007
Children’s Hospital Los Angeles
Los Angeles, California
7
009
Montefiore Medical Center
Bronx, New York
5
014
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington
5
019
Allergy & Asthma Center
Toledo, Ohio
8

 
The above inspections are pending completion. The requested completion date for the inspections is March 28, 2011. We will tell the committee about the results of the inspections as soon as they are available. Should you have any questions about this memo or any aspects of Bioresearch Monitoring, please contact me at 301-827-6335.
 
 
/s/ 
_____________________
Lillian Ortega
Consumer Safety Officer