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Vaccines, Blood & Biologics

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Filing Meeting /STN125350/0/CSL/Pratibha - Hizentra, June 10, 2009

Rana, Pratibha


From: Zhang, Pei
Sent: Wednesday, June 10, 2009 5:30 PM
To: Rana, Pratibha
Subject: RE: Filing Meeting /STN125350/0/CSL/Pratibha

Hi, Pratibha,

I have no issues for filing. This submission is filable.
Thanks!

I'd suggest that we cancel the meeting.
Pei


From: Rana, Pratibha
Sent: Wednesday, June 10, 2009 5:28 PM
To: Ko, Hon Sum
Cc: Zhang, Pei; Frazier, Douglas
Subject: RE: Filing Meeting /STN125350/0/CSL/Pratibha
Importance: High

Hon-Sum,
I have not received filing memos/emails from Doug and Pei.
I can cancel the meeting after I hear from them.

(Pei and Doug, please let me know if you have any issues )
Thanks

Pratibha


From: Ko, Hon Sum
Sent: Wednesday, June 10, 2009 5:23 PM
To: Rana, Pratibha; Zhang, Pei
Subject: RE: Filing Meeting /STN125350/0/CSL/Pratibha

I shall be at a meeting in Arlington at the time of this filing meeting and so cannot participate in the filing discussions if the
meeting is held.
I have no filing issues (see memo in other email).

If the meeting is to be canceled, please let me know.

Thanks.

Hon-Sum.


From: Zhong, Lilin
Sent: Wednesday, June 10, 2009 4:58 PM
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; Frazier, Douglas; Fisher, Robert
Cc: Anderson, Jeffrey; Jain, Nisha
Subject: RE: Filing Meeting /STN125350/0/CSL/Pratibha

Viral clearance in CMC portions are fileable.

Lilin Zhong


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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