
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)

 