Bioresearch Monitoring Filing Memo- TachoSil, July 6, 2009
 
  MEMORANDUM   

   DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
