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Memo of Telecon with Novartis - Agriflu, November 3, 2009

Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research


Date: November 3, 2009

To: File, BL 125297/0

From: Rebecca Olin, CBER/OCBQ/DMPQ/MRBII

Subject: Memo of Telecon with Novartis

On November 3, 2009 I called Joanne Totosy, de Zepetnek, PhD, Vaccine Regulatory Affairs, North America, at Novartis to discuss our conversation of October 1, 2009 and Dr. Totosy’s questions regarding the submission strategy.  In the August 18, 2009 Information Request, Novartis was informed that they could submit filter extractables data in a CBE30 after approval of the BLA.  Dr. Totosy interpreted this as agreement that Novartis could submit their sterile filter data as a CBE30.  I clarified that in the August 18, 2009 IR letter there were also additional questions requesting data to support the equivalence between the --b(4)-------- filters.  Novartis, who subsequently made the decision to submit this data post approval, had not made that decision when the August 18th IR letter was written.  Had they been able to support the use of the ---b(4)--------- filters, then the extractables data could have been submitted as a CBE 30.  However, Novartis, in their ………response, removed the --b(4)--------------- filters from the BLA and committed to submit data to support the use of these filters after approval of the original BLA.  I informed Dr. Totosy that data to support the sterilizing filters would need to be submitted as prior approval supplements or as a Comparability Protocol as was suggested in the October 1, 2009 telecon.