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Vaccines

Record of Telephone Conversation - Agriflu, July 31, 2009

System Info - 107201 MCWATTERS, BERNARD 07-Oct-2009 15:20:18 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: 31-JUL-2009 3:50 PM Initiated by FDA? Yes
Telephone Number:

Communication Categorie(s):
Information Request

Author: BERNARD MCWATTERS

Telecon Summary:
Requesting submission of pediatric study plan from Novartis by August 19.

FDA Participants: Bernard McWatters

Non-FDA Participants: Joanne Totosy de Zepetnek

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:
Hi Joanne,
Things are crazy around here but I was finally able to track down Dr Baylor to get an answer. The actual meeting date for the pediatric review committee is Wednesday August 26. As you said in your email, that means that we will need the pediatric plan by August 19. If it would be helpful to send the plan via secure email before August 19, you are definitely free to do so and I would distribute it to the appropriate reviewers to give them ample time to review the submission. Please have the plan officially submitted by August 19. If the plan is not submitted by then to the file, the meeting could be rescheduled for a later date, and that could delay our schedule. Thanks and have a nice weekend.
JP