Record of Telephone Conversation, August 21, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 21-Aug-2012 04:29 PM Initiated by FDA? Yes
1. Other - Methodology
Author: BRENDA BALDWIN
Possible CTAB ---(b)(4)-- methods
FDA Participants: Brenda Baldwin, Timothy Fritz, Timothy Nelle
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Baldwin, Brenda
Sent: Tuesday, August 21, 2012 4:29 PM
To: 'Gollwitzer, Matthew'
Cc: Fritz, Timothy
Subject: 125408 - CTAB –(b)(4)--- methods
As promised in the teleconference today, we are providing a summary/brief description of -----------(b)(4)-------- methods for the quantitation of CTAB.
Please don't hesitate to contact me if you have any further questions.
4 pages redacted due to (b)(4)