System Info - 106866 MCWATTERS, BERNARD 05-Oct-2009 14:29:51 MCWATTERS
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125297/0 Office: OVRR
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 06-JUL-2009 12:00 AM Initiated by FDA? Yes
Author: BERNARD MCWATTERS
Advice to Novartis regarding their Pediatric study plan for PeRC.
FDA Participants: Bernard McWatters
Non-FDA Participants: Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: McWatters, Bernard [mailto:Bernard.McWatters@fda.hhs.gov]
Sent: Monday, July 06, 2009 9:03 PM
To: Totosy de Zepetnek, Joanne
Subject: Questions discussed this morning...
I was able to speak with Dr. Melisse Baylor about your labeling question and the question about your pediatric study design. As I told you on the phone, Dr. Baylor has had numerous other flu related issues, all with a high level of importance and due as soon as possible and she has not had a chance to review your response to her preliminary comments about the labeling. In discussions with her, she directed me to schedule an internal meeting to discuss the labeling so that we will have comments that follow the current policies for flu vaccines. After this meeting you should get the edited label. I will let you know when this meeting happens and when you can expect comments.
On the pediatric study plan, deferring the 3 month - 3 year age group is not acceptable. We need some sort of plan. The plan does not have to be too detailed, but we need something. Dr. Baylor said that it can be a very brief plan with the expectation that the details will change based on the data from the 3-17 year study population. If you would like to discuss this further, Dr. Baylor and I would be willing to speak with you so that you are clear on what we expect for a plan. Let me know.
I am still in the process of finding out about the outstanding inspectional issues and the review of the --b(4)--- line data.
Bernard J.P. McWatters, Ph.D.
1401 Rockville Pike rm. 379N
Rockville, MD 20852
Office - 301-827-3921