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Vaccines, Blood & Biologics

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Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra , June 11, 2009

Rana, Pratibha


From: Frazier, Douglas
Sent: Thursday, June 11, 2009 11:22 AM
To: Rana, Pratibha; Zhang, Pei; Hu, Jiang; Tanksley, Sarah; Kannan, Bhanu; Ko, Hon Sum;
Mahmood, Iftekhar; QuanderIII, Joseph; Stockbridge, Lisa L; Struble, Evi; Trout, Deborah;
Virata, Maria Luisa; Zhong, Lilin; Fisher, Robert
Cc: Anderson, Jeffrey; Jain, Nisha
Subject: RE: Filing Meeting /STN125350/0/CSL/Pratibha

The original BLA submission STN 125350/0 from CSL Behring AG for their IGSC 20% product is sufficiently complete,
from a CMC point of view, to be acceptable for filing.

Douglas J. Frazier, Biologist
CBER/OBRR/DH/LPD/HFM-345
douglas.frazier@fda.hhs.gov
301 496 9508


From: Rana, Pratibha
Sent: Wednesday, June 10, 2009 4:22 PM
To: Zhang, Pei; Hu, Jiang; Tanksley, Sarah; Kannan, Bhanu; Ko, Hon Sum; Mahmood, Iftekhar; QuanderIII, Joseph; Stockbridge,
Lisa L; Struble, Evi; Trout, Deborah; Virata, Maria Luisa; Zhong, Lilin; Frazier, Douglas; Fisher, Robert
Cc: Anderson, Jeffrey; Jain, Nisha
Subject: Filing Meeting /STN125350/0/CSL/Pratibha

Hello All,

Please enter a filing memo or send me an email stating this BLA is fileable.
Sara T has already entered her memo. If all of you agree that this is fileable and if there are no issues to discuss then
we can cancel the filing meeting. But if there are issues we want to discuss then we should definitely meet tomorrow.
Pratibha

Pratibha Rana, M.S.
Regulatory Project Manager

FDA/CBER/OBRR
Division of Blood Applications
1401 Rockville Pike
Rockville, MD 20852
Office: (301) 827-6124
Fax: (301) 827-2857
email: pratibha.rana@fda.hhs.gov

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