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Vaccines, Blood & Biologics
BIMO Filing Memo, July 01, 2009 - Spherusol
July 01, 2009
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
Bioresearch Monitoring Filing Memo
BLA/STN: 125354/0 Sponsor: Allermed Laboratories, Inc.
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