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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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