
BIMO Filing Memo, July 01, 2009 - Spherusol


 

 

DATE:  
July 01, 2009
  
FROM: 
Dennis T. Cato, Bioresearch Monitoring, HFM-664 
Division of Inspections and Surveillance

Office of Compliance and Biologics Quality

Telephone: 301-827-2588       Fax: 301-827-6748  

SUBJECT: 
Bioresearch Monitoring Filing Memo 
BLA/STN: 125354/0  Sponsor: Allermed Laboratories, Inc. 

TO: 

Sheldon Morris, HFM-431

Ann Schwartz, HFM-475 
Jon Daugherty, HFM-481

Jennifer Bridgewater, HFM-410 



 

 

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

 

 

 

___________________

Dennis T. Cato

Consumer Safety Officer

 

 

Cc:  HFM-664 Access/chron

 

Draft: Cato: 07/01/2009

Reviewed: Holobaugh: 

 
