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Record of Telephone Conversation - Agriflu, September 4, 2009

(System Info - 109223 MCWATTERS BERNARD 10/29/2009 10:24:07 MCWATTERS)


Submission Type: BLA 

Submission ID: 125297/0 

Office: OVRR 

Product: Influenza Vaccine

Applicant: Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 04-Sep-2009 10:00 AM 

Initiated by FDA? Yes Telephone Number: Communication 

Categorie(s): 1. Advice


Brief Description: Spoke with Hilel Cohen in Joanne's absence to clarify exactly that we needed Novartis to submit the 2 pediatric studies, 3-17 years and 6 months to 3 years as PMCsand to clarify that these 2 studies were designed correctly using a licensed comparitor. 

FDA Participants: Bernard McWatters, Douglas Pratt, Melisse Baylor 

Non-FDA Participant(s): Hilel Cohen

Trans-BLA Group : No

Telecon Body:

The purpose of this call was to clarify exactly what was needed by the Pediatric Review Committee (PeRC). In the pediatric study designs, Melisse was still not clear about exactly what licensed comparator that Novartis intended to use. Hilel was able to show in the documents that had already been submitted that they would use the correct licensed comparator. We also told them to submit a document with the 2 studies specified as separate post marketing commitments. We also requested that Novartis provide another commitment to generate a pregnancy registry for Agriflu to which Novartis agreed. They then requested to know the status of the samples that they had submitted to the product release branch. I told them that if I got any information, I would send it to Joanne Totosy de Zepetnek.