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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Information Request Email, February 15, 2012 - Flucelvax

 

From:                    Huang, Ellen (CBER)
Sent:                      Wednesday, February 15, 2012 10:03 AM
To:                         'johnp.barry@novartis.com'
Cc:                         Amin, Pankaj (Pete)
Subject:                 Information Request for STN 125408/0 (Optaflu)
Good morning John,
 
I am one of the reviewers for STN 125408/0 (BLA for Optaflu) and I have the following information request (IR).
 
  • Please provide a description of the columns used in your manufacturing process including the size, dimension, vendor, model number, how the columns are packed and stored, and where each of these columns are used in the process. 
 
Please provide a response through the formal electronic gateway as an amendment to the BLA by 2/28/2012. Feel free to contact me if you have any questions/comments.
 
Thanks,
Ellen Huang
Consumer Safety Officer
FDA/CBER/OCBQ/DMPQ
1401 Rockville Pike, HFM-676
Rockville, MD 20852
Phone: 301.827.7199

Fax: 301.827.3536