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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, August 21, 2012 - Flucelvax

 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Product:
Influenza Vaccine (MDCK Cells)
Applicant:
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
 
Author: BRENDA BALDWIN
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. 
 
[(b)(4)]
 
Please don't hesitate to contact me if you have any further questions.
 
4 pages redacted due to (b)(4)