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Vaccines, Blood & Biologics

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


                                                      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.
Anthony Hawkins
Consumer Safety Officer
HFM-664 AccessChron


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