
Record of Telephone Conversation, August 1, 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: 01-Aug-2012 02:29 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Information Request

 

Author: BRENDA BALDWIN

Telecon Summary:

--(b)(4)----- assay - need more information

FDA Participants: Ellen Huang, Pankaj Amin, Timothy Fritz, Brenda Baldwin

Non-FDA Participants: Matthew Gollwitzer

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

E-mail Body:

 

From:                    Huang, Ellen (CBER) 

Sent:                      Wednesday, August 01, 2012 2:29 PM

To:                         Gollwitzer, Matthew

Cc:                         Amin, Pankaj (Pete); Fritz, Timothy; Baldwin, Brenda

Subject:                 Information Request for STN 125408/0

 

Dear Matthew,

 

I have the following information request for your BLA submission STN 125408/0.

 
- Per US-OPF-016-8 in Amendment 16, you are monitoring for any residual influenza virus by using an assay called -----(b)(4)---------------- after each pandemic production and disinfection of the area. Please provide more information about this assay, including the sensitivity and specificity of the assay.

 

Please submit the requested information as an amendment to STN 125408/0 by August 10, 2012.

Regards,

Ellen Huang