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Vaccines, Blood & Biologics

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Filing Memo Reminder Email, February 8, 2012 am - Octaplas

 

From:                    Ovanesov, Mikhail V.
Sent:                      Wednesday, February 08, 2012 11:17 AM
To:                         Kirschbaum, Nancy
Cc:                         Rana, Pratibha; Lee, Timothy
Subject:                 RE: Reminder Filing memo due: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
Dear Nancy,
 
I briefly reviewed the sections of the submission assigned to me:
3.2.S.3.1              Characterization
3.2.P.3.4              Control of Critical Steps and Intermediates
3.2.P.5.3              Analytical Methods Validation
3.2.P.5.5              Impurities
 
The submission can be filed from my discipline's point of view.
 
This e-mail should serve as my filing memo.
 
Thank you,
--mikhail
 
Mikhail V. Ovanesov, Ph.D.
Visiting Scientist, Principal Investigator
Laboratory of Hemostasis / Division of Hematology / Office of Blood Research and Review
Center for Biologics Evaluation and Research / U.S. Food & Drug Administration
Office: (301) 827-4026 Fax: (301) 402-2780 Cell: (240) 731-0308
29 Lincoln Drive, N29/309, Bethesda, MD 20892                                                    
Mail: FDA/CBER ; HFM 340 ; 1401 Rockville Pike, Rockville, MD 20852
 
 
_____________________________________________
From: Rana, Pratibha
Sent: Wednesday, February 08, 2012 11:06 AM
To: Jain, Nisha; Lee, Timothy; Mahmood, Iftekhar; Stockbridge, Lisa L; Holobaugh, Patricia; Austin-Hansberry, Lori; Kim, Jessica; Rees, Renee; Boxenbaum, Harold; Green, Damon; Kirschbaum, Nancy; Drabick, Christine; Malla, Amy; He, Jie; Brony, Michael; Frost, Mitchell M; Kirschbaum, Nancy; Mullersman, Jerald; Kim, Jessica; Melhem, Randa; Peng, Ze; Ovanesov, Mikhail V.; Wyatt, Michael (Keith)
Subject: Reminder Filing memo due: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
 
 
Hello All,
This is a reminder to upload your signed off Filing memo by Friday February 10, 2012.
If you are writing a filing memo as email please CC me and the chairperson, Nancy Kirshbaum.
Thanks
Pratibha
 
_____________________________________________
From:                    Rana, Pratibha 
Sent:                      Thursday, January 05, 2012 1:38 PM
To:                         Rana, Pratibha; Rana, Pratibha; Jain, Nisha; Lee, Timothy; Mahmood, Iftekhar; Stockbridge, Lisa L; Holobaugh, Patricia; Austin-Hansberry, Lori; Kim, Jessica; Rees, Renee; Boxenbaum, Harold; Green, Damon; Kirschbaum, Nancy; Drabick, Christine; Malla, Amy; He, Jie; Brony, Michael; Frost, Mitchell M; Kirschbaum, Nancy; Mullersman, Jerald; Kim, Jessica; Melhem, Randa; Peng, Ze; Ovanesov, Mikhail V.; Wyatt, Michael (Keith)
Subject:                 Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
When:                    Tuesday, February 07, 2012 1:00 PM-2:00 PM (GMT-05:00) Eastern Time (US & Canada).
Where:                  CBER Conf. WOC-400S
 
( if you are unable to attend in person and by phone) please send an email answering the following topics to SL, Nancy Kirshbaum and me).
 
STN 125416/0
Product: Pooled Plasma, Solvent Detergent Treated (Human)
Sponsor: Octapharma
 
Filing Meeting:
To determine if this BLA is fileable/RTF/Deficiencies
Decision on priority review or not
 
 
Call in info for those who cannot attend in person:
 
----(b)(4)--------
Participant code: --(b)(4)-----
 
Thanks
Pratibha
 
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