Record of Telephone Conversation, January 30, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 30-Jan-2012 10:21 AM Initiated by FDA? Yes
1. Other - Request for in-process samples for testing
Author: TIMOTHY FRITZ
Monovalent and trivalent bulk samples for in-process testing.
FDA Participants: Timothy Fritz
Non-FDA Participants: John P. Barry, Ingeborg Cebulla
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Monday, January 30, 2012 10:21 AM
To: 'Barry, JohnP'
Cc: 'Cebulla, Ingeborg'
Subject: Request for Samples for in-support testing STN 125408 (Optaflu)
Dear Dr. Barry-
CBER requests that Novartis submit samples of OPTAFLU to CBER for testing. CBER requests that Novartis submit 3 lots of each strain of monovalent bulk (9 total samples, 20 mL sample per lot per strain) and 3 lots of formulated trivalent bulk (6 samples of each lot for a total of 18 samples at 20 mL per sample). Please send these samples to the following address:
Regulatory Coordinator (DBSQC)