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Vaccines, Blood & Biologics

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Filing Meeting, February 8, 2012 - Octaplas

From:                    He, Jie

Sent:                      Wednesday, February 08, 2012 11:38 AM
To:                         Rana, Pratibha; Kirschbaum, Nancy
Cc:                         Michaelis, Marion; Melhem, Randa
Subject:                 RE: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
Hi, Pratibha and Nancy:
 
Based on cursory review of the submission regarding all DMPQ responsible items, DMPQ has not identified issues that would prevent this BLA from being filed.
 
Team BIO has just came back from inspection of the Stockholm facility and the inspection will likely be classified as VAI if all previous observations were verified as been corrected. DMPQ has not made decision on if the pre-approval inspection would be waived.
 
Thanks,
 
Jie He
CBER/OCBQ/DMPQ/MRBII
Phone: 301.827.0183
 
_____________________________________________
From: Rana, Pratibha
Sent: Monday, February 06, 2012 4:55 PM
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: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
 
Hello All,
Here is the Pre-IND meeting minutes if you don’t have it already.
 << File: Final Meeting summary_Octapharma_CRMTS 6508.pdf_ceritfied.pdf >>
Pratibha