DATE: December 07, 2010
The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.
Vaccines, Blood & Biologics
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.
Consumer Safety Officer
Draft: Ortega: 12/07/2010