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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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: