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
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