System Info - 107053 MCWATTERS, BERNARD 06-Oct-2009 17:56:10 MCWATTERS
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application
Submission ID: 125297/0
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 04-SEP-2008 12:00 AM
Initiated by FDA? Yes
2. Information Request
Author: BERNARD MCWATTERS
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
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?
Bernard J.P. McWatters, Ph.D.