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Vaccines, Blood & Biologics
Information Request Email, February 15, 2012 - Flucelvax
From: Huang, Ellen (CBER)
Sent: Wednesday, February 15, 2012 10:03 AM
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.
Consumer Safety Officer
1401 Rockville Pike, HFM-676
Rockville, MD 20852