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Vaccines

Record of Telephone Conversation Discussion of Issues - Agriflu, July 6, 2009

(System Info - 109751 MCWATTERS BERNARD 11/03/2009 06:29:42 MCWATTERS)

RECORD OF TELEPHONE CONVERSATION 

Submission Type: BLA

Submission ID: 125297/0 

Office: OVRR Product: Influenza Vaccine 

Applicant: Novartis Vaccines and Diagnostics, Inc. 

Telecon Date/Time: 06-Jul-2009 12:00 AM

Initiated by FDA? No

Telephone Number: 

Communication Categorie(s): 

1. Advice 

Author: BERNARD MCWATTERS 

Brief Description: Discussed issues involving PMCs, labeling, --b(4)------ data, pediatric plan and LRP. 

FDA Participants: Bernard J.P. McWatters 

Non-FDA Participant(s): Joanne Totosy de Zepetnek Trans-BLA Group : No
Related STNS :

Related PMCs : 

Telecon Body: 

Joanne called me in order to ask me several questions about the status of the application. We discussed 2 inspection related issues that the sponsor wants to have as PMCs. I told Joanne that was not likely but I would speak with Anissa Cheung to find out what her take on the issues was and if the issues should be corrected prior to approval.

 

She then asked me about the status of the PI and I told her that the most recent feedback that I had gotten from Melisse Baylor is that there is still a significant amount of work to be done but I would check with her again to see if there was any update.

The next issue that she asked me about was the review of amendment 6 which was the data about the --b(4)--- filling line, -b(4)_. I told her that I needed to check with Rebecca Olin to find out any information about that.

 

She then asked me about the pediatric plan that had been requested and submitted for review. I told her that I would get back to her with feedback about this from Dr. Baylor and if it was needed Dr. Baylor and I would directly discuss any areas of confusion about the plan.

 

Her last question was confirmation that the documents that they had provided to DPQ with the samples were correct. I told her that I would contact her if there was a problem with the documentation.