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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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12/12/2008 Telecon - RiaSTAP

Memorandum

From:Laura Wood, OBRR/DH/LH
To: The file of STN 125317/0 and Vasantha Kumar, OBRR/DBA/RPMB
Company:CSL Behring GmbH
Product:Fibrinogen Concentrate (Human), RiaSTAP™
Subject:Telephone call with David Desris

Summary

 On December 12, 2008, Mr. Desris called to see when the company would be receiving a communication from CBER regarding the pharmacovigilance and labeling reviews. I told him that we hoped to send something by the end of that week