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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Bioresearch Monitoring Filing Memo, July 13, 2010 - Isoplate Solution

 

MEMORANDUM               DEPARTMENT OF HEALTH AND HUMAN SERVICES
                                                      Public Health Service
                                                      Food and Drug Administration
                                                      Center for Biologics Evaluation and Research
_____________________________________________________________________
 
DATE:          July 13, 2010
 
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
 
SUBJECT:    Bioresearch Monitoring Filing Memo
                    NDA:  BN090067  
                    Sponsor: B. Braun Medical Inc.  
 
TO:              Jan Simak               HFM-335 
Iliana Valencia        HFM-370
                   
Based upon my initial review of the clinical data contained within this electronic submission, the submission appears fileable.
 
 
 
/s/ 
_____________________
Anthony Hawkins
Consumer Safety Officer
 
 
 
Cc:    
HFM-664 AccessChron