Record of Telephone Conversation, May 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-May-2012 03:49 PM Initiated by FDA? Yes
Telephone Number: Conveyed via e-mail
1. Information Request
Author: TIMOTHY FRITZ
Audit report for Site 01, study V58P9 if available.
FDA Participants: Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Wednesday, May 09, 2012 3:49 PM
To: 'Gollwitzer, Matthew'
Subject: CBER Information Request for STN 125408 (Optaflu)
Dear Mr. Gollwitzer-
Our review of STN 125408 (Optaflu) is ongoing. Please clarify whether an audit of Site 01 (Vilnius University Hospital) for clinical lot consistency study V58P9 was conducted by Lithuanian authorities or Novartis. If so, please provide us with the audit report within the next two weeks.
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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