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Vaccines, Blood & Biologics

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:

Study Site
Children’s Hospital Los Angeles
Los Angeles, California
Montefiore Medical Center
Bronx, New York
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington
Allergy & Asthma Center
Toledo, Ohio

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.
Lillian Ortega
Consumer Safety Officer

Page Last Updated: 01/18/2013
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