Record of Telephone Conversation, April 13, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 13-Apr-2012 01:00 PM Initiated by FDA? Yes
Telephone Number: Conveyed via e-mail
1. Information Request
Author: TIMOTHY FRITZ
Lithuanian report of Site 2 audit
FDA Participants: Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Friday, April 13, 2012 1:00 PM
To: 'Gollwitzer, Matthew'
Subject: CBER Information Request for STN 125408
Dear Mr. Gollwitzer-
To facilitate our review of Study V58P9, please submit an English translation of the Lithuanian Competent Authority audit of Site 2 as an amendment to BLA 125408 at your earliest convenience but no later than April 27, 2012.
If you have any questions, please contact the Regulatory Project Manager, Drs Brenda Baldwin or Timothy Fritz, at 301-796-2640 or via e-mail.
Timothy A. Fritz, Ph.D.
1451 Rockville Pike
Rockville, MD 20852
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