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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, October 5, 2012 cont - Flucelvax

 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Product:
Influenza Vaccine (MDCK Cells)
Applicant:
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 05-Oct-2012 11:00 AM        Initiated by FDA? Yes
Telephone Number: 617871-8325
Communication Categorie(s):
1. Information Request
 
Author: TIMOTHY NELLE
Telecon Summary:
CTAB Data from in processing steps ----(b)(4)------
FDA Participants: Timothy Nelle
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
 
CBER requests CTAB measurement data for process monitoring points (b)(4) ------------------------------------------------(b)(4)----------------. The amount of data to be submitted should represent at least 3 release lots.   In other words, we expect that CTAB results from each batch that is ultimately used to constitute three trivalent lots will be included in NVD’s response to this request.