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Record of Telephone Conversation - Agriflu, July 27, 2009

(System Info - 109212 MCWATTERS BERNARD 10/29/2009 09:47:57 MCWATTERS)


Submission Type: BLA 

Submission ID: 125297/0 

Office: OVRR 

Product: Influenza Vaccine

Applicant: Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 27-Jul-2009 04:00 PM

Initiated by FDA? Yes 

Telephone Number: Communication 

Categorie(s): 1. Advice


Brief Description:
Melisse Baylor and I called Joan Totosy de Zepetnek to clarify exactly what pediatric studies were needed to present to the Pediatric Review Committee. 

FDA Participants:
Melisse Baylor and Bernard J.P. McWatters Non-FDA Participant(s): Joanne Totosy de Zepetnek
Trans-BLA Group : No 

Telecon Body:
Novartis had submitted pediatric studies that were unacceptable based on what the Pediatric Review Committee (PeRC) needs to make their decision. During this conversation we clarified that Novartis needs to submit a study design with subjects from 3 to 17 years old with a comparator that is licensed for use in the US down to 3 years of age and not Fluvirin which is only licensed for use in a pediatric population that is at least 4 years old. We also told her that we needed a separate study designed for a pediatric population from 6 months to 3 years as long as the other study was properly designed. We told her that a study in patients 0-6 months was not necessary because we were going to request a waiver from PeRC for that age group. We also informed her that these studies would be post marketing commitments.