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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bioresearch Monitoring Filing Memo, April 19, 2012 - Kcentra

Memorandum                                                                                                                          Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research


DATE:          April 19, 2012
 
FROM:         Anthony Hawkins, Bioresearch Monitoring, HFM-664
                    Division of Inspections and Surveillance
                   Office of Compliance and Biologics Quality
                    Telephone: 301-827-6338            Fax: 301-827-6748
 
THROUGH: Patricia Holobaugh, Chief, Bioresearch Monitoring Branch HFM-664
 
SUBJECT:    Bioresearch Monitoring Filing Memo
                    BLA/STN: 125421-0         
                  Sponsor:   CSL Behring GmbH  
 
TO:              Ze Peng, BLA Committee Chair             HFM-392               
                   Leland Pierce, Clinical Reviewer             HFM-392
                   Beth Walton, RPM                                 HFM-380
                   
Based upon my initial review of the clinical data contained within this electronic submission, the submission appears fileable.
 
 
 
 
_____________________
Anthony Hawkins
Consumer Safety Officer