
Record of Telephone Conversation, January 30, 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: 30-Jan-2012 10:21 AM        Initiated by FDA? Yes

 

Telephone Number:

 

Communication Categorie(s):

1. Other - Request for in-process samples for testing

 

Author: TIMOTHY FRITZ

Telecon Summary:

Monovalent and trivalent bulk samples for in-process testing.

 

FDA Participants: Timothy Fritz

Non-FDA Participants: John P. Barry, Ingeborg Cebulla

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

 

Telecon Body:

From:                    Fritz, Timothy

Sent:                      Monday, January 30, 2012 10:21 AM

To:                         'Barry, JohnP'

Cc:                         'Cebulla, Ingeborg'

Subject:                 Request for Samples for in-support testing STN 125408 (Optaflu)

 

Importance:           High

 

Dear Dr. Barry-

 

CBER requests that Novartis submit samples of OPTAFLU to CBER for testing. CBER requests that Novartis submit 3 lots of each strain of monovalent bulk (9 total samples, 20 mL sample per lot per strain) and 3 lots of formulated trivalent bulk (6 samples of each lot for a total of 18 samples at 20 mL per sample). Please send these samples to the following address:

 

Karen Campbell

Regulatory Coordinator (DBSQC) 
OCBQ/CBER/FDA