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Record of Telephone Conversation, August 1, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 01-Aug-2012 02:29 AM Initiated by FDA? Yes
1. Information Request
Author: BRENDA BALDWIN
--(b)(4)----- assay - need more information
FDA Participants: Ellen Huang, Pankaj Amin, Timothy Fritz, Brenda Baldwin
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Huang, Ellen (CBER)
Sent: Wednesday, August 01, 2012 2:29 PM
To: Gollwitzer, Matthew
Cc: Amin, Pankaj (Pete); Fritz, Timothy; Baldwin, Brenda
Subject: Information Request for STN 125408/0
I have the following information request for your BLA submission STN 125408/0.
- Per US-OPF-016-8 in Amendment 16, you are monitoring for any residual influenza virus by using an assay called -----(b)(4)---------------- after each pandemic production and disinfection of the area. Please provide more information about this assay, including the sensitivity and specificity of the assay.
Please submit the requested information as an amendment to STN 125408/0 by August 10, 2012.