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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, December 23, 2011 - Flucelvax

 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Product:
Influenza Vaccine (MDCK Cells)
Applicant:
Novartis Vaccines and Diagnostics GmbH
Telecon Date/Time: 23-Dec-2011 01:09 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice
Author: TIMOTHY FRITZ
Telecon Summary:
Clarification for SRID test results submission.
FDA Participants: Timothy Fritz
Non-FDA Participants: Ingeborg Cebulla, John Barry
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
 
Telecon Body:
From:                    Fritz, Timothy
Sent:                      Friday, December 23, 2011 1:09 PM
To:                         'ingeborg.cebulla@novartis.com'
Cc:                         'john.barry@novartis.com'
Subject:                 CBER clarification for SRID testing
 
Importance:           High
 
Dear Dr. Cebulla-
 
Novartis and CBER held a teleconference on November 17, 2011, to discuss SRID testing of Novartis' MDCK cell-based influenza antigens. CBER received a summary of the discussion from Novartis via e-mail on November 18, 2011. In this e-mail, Novartis indicated that CBER recommended that Novartis submit an amendment to the Optaflu BLA "if cell based reagents need to be developed and used."
 
CBER wishes to clarify that it also recommends that Novartis submit assay results of SRID experiments assessing the suitability of egg-based influenza reagents in the event that those results support the use of egg-based reagents for measuring the potency of the MDCK cell-produced influenza antigens. CBER recommends that these results be submitted as an amendment to the Optaflu BLA (STN 125408). CBER would appreciate an estimate of when Novartis expects to complete the suitability study.
 
If you have any questions, please contact the Regulatory Project Managers, Dr. Brenda Baldwin or Dr. Timothy Fritz, at 301-796-2640 or via e-mail.
 
Thank you.
Timothy A. Fritz, Ph.D.
Microbiologist
FDA/CBER/OVRR/DVRPA/CMC2
WOC2 HFM-478
1451 Rockville Pike
Rockville, MD 20852
Phone: 301-796-2640
Fax: 301-827-1597
 
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