
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