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Vaccines

Record of Telephone Conversation - Agriflu, September 4, 2008

System Info - 107053 MCWATTERS, BERNARD 06-Oct-2009 17:56:10 MCWATTERS

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application 

Submission ID: 125297/0 

Office: OVRR

Product:
Influenza Vaccine

Applicant:
Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 04-SEP-2008 12:00 AM 

Initiated by FDA? Yes
Telephone Number:

Communication Categorie(s):
1. Advice
2. Information Request

Author: BERNARD MCWATTERS

Telecon Summary:
Requested information on the due diligence used when attempting to obtain financial disclosures from Clinical investigators. Also provided information about-b(4)- assay.

FDA Participants: Bernard McWatters

Non-FDA Participants: Joanne Totosy de Zepetnek

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

Joanne,

In response to your voicemail regarding financial disclosure, please describe what due diligence was performed by Novartis in attempting to obtain the necessary information from your clinical investigators in the financial disclosure process.

In regards to the -b(4)- testing; you should use CBER reagents, which are available for the current influenza strains. These tests will be completed after the BLA submission, and the results should be provided in a timely way. Please note that for release of trivalent bulks -b(4)- testing should be performed using CBER’s methodology which is available upon request. Exactly when do you plan to submit the data obtained in the -b(4)-- assay performed using CBER reagents to the BLA?

JP

Bernard J.P. McWatters, Ph.D.
FDA/CBER/OVRR/DVRPA