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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Meeting Email, February 7, 2012 - Octaplas

 

From:                    Peng, Ze
Sent:                      Tuesday, February 07, 2012 3:24 PM
To:                         Rana, Pratibha; Kirschbaum, Nancy
Cc:                         Lee, Timothy
Subject:                 RE: Filing Meeting/STN 125416/0/OctaplastLG from Octapharma
 
Good afternoon, Pratibha and Nancy:
 
Regarding the original BLA under STN 125416 submitted by Octapharma for Solvent/Detergent treatment human plasma, OctaplasLG, I did a preliminary review on two sections, Stability (3.2.S.7 and 3.2.P.8) and Adventitious Agents Safety Evaluation (3.2.A.2). I found that the information provided in these sections will allow me to perform a meaningful review. Therefore, this submission can be filed.
 
Thanks
 
Ze