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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, August 31, 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: 31-Aug-2012 09:15 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice
2. Information Request
 
Author: TIMOTHY NELLE
Telecon Summary:
--(b)(4)-- CTAB and PS80 assays
FDA Participants: Brenda Baldwin, Timothy Fritz, Anissa Cheung, Karen Campbell, Zhiping Ye, Lokesh Bhattacharyya, William McCormick
Non-FDA Participants: Matthew Gollwitzer, Kerstin Platz, Reinhard Wilms, Manfred Brunen, Stefan Knapp, Holger Kost, Karsten Kattmann
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
 
This meeting was held to discuss the-----------------------(4)(4)------------------------------------------------------------developing and validating new assays for CTAB and polysorbate 80. ----------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------- validation package to support revised or new CTAB and P80 assays.
 
CBER stressed that the CTAB assay was a safety issue due to concerns with toxicity that has been associated with CTAB. As such, CBER believes it is important to implement a more sensitive CTAB assay as soon as possible. To assist, CBER offered to provide suggested alternative CTAB assays for Novartis’ consideration. In turn, Novartis accepted this offer, committed to working with Dr. Gupta’s lab on the development of these assays, and offered to provide progress reports.
 
Novartis stated that 3 months was not enough time to develop these assays and estimated that 6 months would be needed to develop properly validated assays and submit the reports to CBER.  CBER concurred.
 
Because of CBER concerns with CTAB cytotoxicity, ----------------(b)(4)------------------------------------------------------------------------- validated assays for CTAB and P80.