Record of Telephone Conversation, August 9, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 09-Aug-2012 02:32 PM Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
1. Information Request
Author: TIMOTHY FRITZ
FDA Participants: Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Thursday, August 09, 2012 2:32 PM
To: 'Gollwitzer, Matthew'
Subject: CBER information request for STN 125408 (Flucelvax)
Dear Mr. Gollwitzer-
Our review of STN 125408 (Flucelvax) is ongoing. Please provide a narrative report for study V58P13 Subject 05/390. To expedite our review, you may provide your response via e-mail. Please respond no later than August 17.
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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