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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bioresearch Monitoring Filing Memo- TachoSil, July 6, 2009


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

DATE: July 06, 2009
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: 125351/0             Sponsor: Nycomed Danmark ApS
TO:Jie He                                 HFM-380
Kimberly Lindsey                HFM-392
Natalya Ananyeva               HFM-392

Based upon my initial review of the clinical data contained within this electronic submission, the submission appears fileable.


Lillian Ortega
Consumer Safety Officer