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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, August 15, 2012 - Flucelvax

 

Report of Telephone Conversation
 
Date/Time of Call:                             August 15, 2012 @ 3:30 PM
 
CBER Representative:                     Ellen Huang, CSO, CBER/OCBQ/DMPQ/MRBII
Pete Amin, Reviewer, CBER/OCBQ/DMPQ/MRBII
Chiang Syin, Ph.D., Branch Chief, CBER/OCBQ/DMPQ/MRBII
Laurie Norwood, Deputy Division Director, CBER/OCBQ/DMPQ
Marion Michaelis, Team Leader, CBER/OCBQ/DMPQ/MRBII
 
Organization Representative:          Matthew Gollwitzer, Regulatory
John Barry, Regulatory
 
Organization:                                    Novartis Vaccines and Diagnostics
                                                           
Telephone:                                         (617) 871 8427
 
Subject:                                              BLA STN 125408/0
 
STN:                                                   STN 125408/0
                       
 
We contacted Novartis to discuss the license holder of the submission.
 
We asked Novartis who the license holder for the submission was. They said it would be Novartis Vaccines & Diagnostics, Inc. We explained then Novartis Vaccines & Diagnostics Gmbh in Marburg would be considered a contractor since they have a separate license number. Therefore, Novartis Inc would need to have a quality agreement with Novartis Gmbh. Also, if Novartis Gmbh made a change, Novartis Inc would be responsible for notifying the Agency of the change. Novartis Inc would not be able to bundle the change with Novartis Gmbh products.
 
We asked them to submit to the file in writing confirming that this is their intentions. They agreed.
 
Call Ended at 3:45 PM