Record of Telephone Conversation - Agriflu, July 30, 2008

System Info - 107199 MCWATTERS, BERNARD 07-Oct-2009 15:08:21 MCWATTERS

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application Submission ID: 125297/0 Office: OVRR

Product:
Influenza Vaccine

Applicant:
Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 30-JUL-2008 12:00 AM 

Initiated by FDA? Yes
Telephone Number:

Communication Categorie(s):
Information Request

Author: BERNARD MCWATTERS

Telecon Summary:
Requested programs used by Novartis to analize raw data so the CBER statistical reviewer can repeat the analysis. Novartis agreed to submit these programs in pre-BLA discussions.

FDA Participants: Bernard J.P. McWatters

Non-FDA Participants: Joanne Totosy de Zepetnek

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

Joanne,

I got your message that you called a couple of days ago. As of now, the review of your BLA is ongoing. We are currently in the process of deciding if the BLA can be filed and if it can, if there are any deficiencies. The filing deadline is 60 days after we received the BLA. We will let you know at that point if the BLA will be filed. I am still expecting you to send in the programs that the statistical reviewer on the team can use to analyze your data sets. I remember that you told me that this will happen within a month of submission. Make sure that these programs are submitted in a timely manner. Thanks.
JP

Bernard J.P. McWatters, Ph.D.
FDA/CBER/OVRR/DVRPA
HFM-478
1401 Rockville Pike rm. 389N
Rockville, MD 20852
Office - 301-827-5379