• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

Record of Telephone Conversation, April 13, 2012 - Flucelvax

 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Product:
Influenza Vaccine (MDCK Cells)
Applicant:
Novartis Vaccines and Diagnostics, Inc.
 
Telecon Date/Time: 13-Apr-2012 01:00 PM        Initiated by FDA? Yes
 
Telephone Number: Conveyed via e-mail
Communication Categorie(s):
1. Information Request
 
Author: TIMOTHY FRITZ
 
Telecon Summary:
Lithuanian report of Site 2 audit
 
FDA Participants: Timothy Fritz
 
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
 
Telecon Body:
From:                    Fritz, Timothy
Sent:                      Friday, April 13, 2012 1:00 PM
To:                         'Gollwitzer, Matthew'
Subject:                 CBER Information Request for STN 125408
 
Importance:           High
 
Dear Mr. Gollwitzer-
 
To facilitate our review of Study V58P9, please submit an English translation of the Lithuanian Competent Authority audit of Site 2 as an amendment to BLA 125408 at your earliest convenience but no later than April 27, 2012.
 
If you have any questions, please contact the Regulatory Project Manager, Drs Brenda Baldwin or Timothy Fritz, at 301-796-2640 or via e-mail.
 
Thank you.
Timothy A. Fritz, Ph.D.
Microbiologist
FDA/CBER/OVRR/DVRPA/CMC2
WOC2 HFM-478
1451 Rockville Pike
Rockville, MD 20852
Phone: 301-796-2640
Fax: 301-827-1597
 
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify the sender immediately by e-mail or phone.