System Info - 107221 MCWATTERS, BERNARD 07-Oct-2009 16:43:35 MCWATTERS
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125297/0 Office: OVRR
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 21-SEP-2009 12:00 AM Initiated by FDA? No
Author: BERNARD MCWATTERS
Corrected dates for pediatric studies to be submitted to PeRC.
Non-FDA Participants: Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
In response to the committee's request in your email below, our commitment statement in the letter has been revised as follows:
Novartis is hereby committing to provide to the Agency the following items as Post-Approval Commitments for AGRIFLU:
- Novartis will provide a study protocol, conduct a clinical study, and subsequently provide results that evaluate use of AGRIFLU in children 3 years to 17 years of age.
- Novartis will provide a study protocol, conduct a clinical study, and subsequently provide results that evaluate use of AGRIFLU in children 6 months to 35 months of age.
- Novartis will establish a pregnancy registry for subjects that receive AGRIFLU.
We anticipate that the clinical study in the 3 to 17 years of age population will be started in September 2010 and finish approximately one year later (September 2011). Final results of this study are planned to be submitted to the Agency in January 2012. After the safety and immunogenicity data from this study are available, a clinical study in the 6 to 35 months of age group will be initiated, potentially in September 2011, and finish approximately one year later (September 2012). Final results of the second study are planned to be submitted to the Agency in January 2013.
The revised letter to be submitted through the gateway today is attached.
Once again, can you please confirm that the revisions to the attached letter addresses all of the committee's concerns and that the PeRC meeting will proceed on September 23, 2009 as scheduled?