• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu


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
Telephone Number:
Communication Categorie(s):
1. Other - Methodology
Telecon Summary:
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
E-mail Body:
From:     Baldwin, Brenda 
Sent:                      Tuesday, August 21, 2012 4:29 PM
To:                         'Gollwitzer, Matthew'
Cc:                         Fritz, Timothy
Subject:                 125408 - CTAB –(b)(4)--- methods
Hi Matt,
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)