
Bioresearch Monitor Filing Memo, December 7, 2010 - Bivigam

 
 
DATE:          December 07, 2010

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: 125389/0           Sponsor: Biotest Pharmaceuticals Corporation

 

TO:              Pratibha Rana                   HFM-380

                   Michael Kennedy               HFM-345 

                   Mitchell Frost                              HFM-392

                    

Based upon my initial review of the clinical data contained within this electronic submission, the submission appears fileable.

 

 

 

/s/ 

_____________________

Lillian Ortega

Consumer Safety Officer

 

 

 

Cc:     

HFM-664 AccessChron

          

Draft: Ortega: 12/07/2010

Reviewed: Holobaugh