System Info - 106863 MCWATTERS, BERNARD 05-Oct-2009 14:23:25 MCWATTERS
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125297/0 Office: OVRR
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 08-JUL-2009 09:50 AM Initiated by FDA? No
Author: BERNARD MCWATTERS
Novartis emailed me to request an update on several issues that were discussed in a July 6th telephone conversation.
FDA Participants: Bernard J.P. McWatters
Non-FDA Participants: Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Thank you for taking my call on Monday and for your quick email response below. This has been a challenging period for follow up since we filed the Complete Response on May 29, 2009 (BLA amendment 0016).
During our conversation on Monday July 6th you told me the following:
CBER will re-review the AGRIFLU name; this is a standard approach by the Agency to proprietary name approval.
A meeting has been scheduled for July 17, 2009 for the review team to discuss our Complete Response.
You have asked the review team to complete their reviews by the end of July 2009.
During our conversation we also reviewed the Complete Response (CR) cover letter and discussed the outstanding Company requests in order of priority for Novartis. A summary of our discussion is provided below:
1) Post-marketing commitments
In the CR cover letter Novartis proposed that two outstanding inspectional issues identified in the FDA Form 483 (dated 13 Feb 2009) be accepted as post-approval commitments:
(1) Hold time validation data from the 2009-2010 B strain (reference to Question 2, and Question 17; 483 inspectional observation 2, commitment 1b)
(2) Repeat the cleaning validation study of the Inoculation Machine (reference to 483 inspectional observation 4, commitment 2)
The Company is seeking agreement from CBER that these two data packages will be accepted and reviewed as post-approval commitments, such that the review of these data will not delay approval of the BLA.
FOLLOW UP: JP McWatters will discuss this with the review committee chair (Anissa Cheung).
2) Timing of labelling approval to permit supply for the 2009-2010 season
In the CR cover letter Novartis proposed to "submit the 2009-2010 strain change supplement information (passage history and QC release data for the working seed, and updated labeling with the United States 2009-2010 seasonal influenza vaccine formulation) in a subsequent amendment to this BLA for approval at the same time as the BLA approval."
In the absence of a response from CBER on this proposal, Novartis submitted the strain change supplement information on June 16, 2009 as BLA amendment 0017. Samples of working seed have been shipped to CBER for testing.
It was acknowledged that no feedback has been received from CBER on the proposed label submitted April 14, 2009, or the updated label with 2009-2010 strain information submitted June 16, 2009. J Totosy emphasized that in order to permit supply of AGRIFLU this season, contracts for printing of labeling materials must be established very soon. This activity cannot begin until the labeling text is approved.
FOLLOW UP: JP McWatters will discuss the status of the label review with the lead reviewer (Dr. Melisse Baylor)
Response to your email below: Novartis acknowledges and appreciates the "numerous other flu related issues" Dr. Baylor has had to contend with recently. We respectfully request that the internal meeting Dr. Baylor has requested to discuss our labeling be scheduled at the earliest possible time. Novartis is seeking approval of the labeling by the end of July 2009. Once again, the Company would like to emphasize that, if approved, AGRIFLU could be an additional platform for future US supply of H1N1 pandemic vaccine. We are utilizing this platform to ----b(4)---------------------------------------.
3) Status of ---b(4)-----
It was acknowleged that the data package for the addition of --b(4)-- syringes to the pre-filled syringe filling line, --b(4)-- (submitted Feb 26, 2009 as BLA amendment 0006) was not completely reviewed prior to the April 27, 2009 Action Letter from CBER.
J Totosy requested an update on the status of review of this data package since the Company plans to use this line for production of AGRIFLU this season.
FOLLOW UP: JP McWatters will discuss with DMPQ reviewer (Rebecca Olin) to determine the status of this review.
4) Pediatric plan
J Totosy requested feedback on the Company's request for deferral in the CR cover letter (i.e., to defer the study of children younger than 3 years of age). It was noted that the protocol for the study of children 3 to 17 years was previously submitted to CBER for review.
JP McWatters spoke to Dr. Baylor about the pediatric plan for AGRFLU last week, and will follow up with her again to determine specifically what further information is required.
Response to your email below: We appreciate your offer to have a telecon with Dr. Baylor to get clarity on expectations for the pediatric plan. How soon can this be schedued?
5) Updated lot release protocol
The lot release protocol has been updated to include the tests for CTAB and Polysorbate 80 on the trivalent bulk samples. This protocol (unexecuted) and the documents supporting the addition of the two new tests will be submitted in the final BLA amendment planned for submission next week.
JP McWatters received comments from DPQ (Bill McCormick's group) on the lot release protocol Novartis submitted on April 9, 2009 (BLA amendment 0012). This protocol was also included with the requested MPH and formulated trivalent bulk samples shipped to CBER on March 27, 2009. DPQ has commented that the protocol was not what they were expecting. J Totosy confirmed that the lot release protocol submitted by Novartis was modified to be consistent with the template provided by Dr. Rajesh Gupta.
FOLLOW UP: JP McWatters will discuss with DPQ to ensure they received the right documents. J Totosy will re-send the lot release protocols and other documentation that accompanied the samples to JP McWatters.
Joanne Totosy de Zepetnek, PhD
Vaccine Regulatory Affairs - North America
Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue
Cambridge, MA 02139-4182
Tel: (617) 871-7929
Fax: (617) 871-4711
Mobile: (617) 460-2376