(System Info - 110469 MCWATTERS BERNARD 11/10/2009 11:14:39 MCWATTERS)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125297/0 Office: OVRR
Product: Influenza Vaccine
Applicant: Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 12-Jan-2009 06:58 PM
Initiated by FDA? No
Communication Categorie(s): 1. Other -
Author: BERNARD MCWATTERS
Telecon Summary: Novartis asked about data files submitted, PNR, strain change and the formatting of their electronic submissions.
FDA Participants: Bernard McWatters
Non-FDA Participants: Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
To follow up on the voice message I left you earlier today, there are 4 things I would like your feedback on.
- Incorrect clinical data files - HI retest data
It has come to my attention that 3 clinical data files need to be replaced as the wrong files were submitted in the original Agrippal BLA:
V58P2: both LABSEDT.XPT and SAMPLEVU.XPT
We plan to submit these 3 replacement files later this week. Please let me know if you have any questions.
- Request for Proprietary Name
Novartis originally filed a request to review the proposed Agrippal Brand Name to BB-IND -b(4)--on 22-Mar-2007 (S/N 0001). The name was accepted with concerns, and we were asked to request another proprietary name review closer to the time of approval (see attached response dated 31-Mar-2008). I was planning to file the new request to the IND, like the last one, and would like you to confirm that this approach is acceptable.
- 2009 Annual Strain Change Update
The Annual Strain Change Updates are usually filed in the March-April time frame. Since this is prior to the BLA Action Date, we will need to file this data package as an amendment to the BLA. Do you agree?
- Format of 125297/0002
Please confirm that the format of Amendment 0002 is acceptable. If so, we will model the remaining amendments accordingly.
That's it for now. Let me know if you have any questions.
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