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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, August 9, 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: 09-Aug-2012 02:32 PM        Initiated by FDA? Yes
 
Telephone Number: Communicated via e-mail
 
Communication Categorie(s):
1. Information Request
 
Author: TIMOTHY FRITZ
 
Telecon Summary:
SAE narrative.
 
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:                      Thursday, August 09, 2012 2:32 PM
To:                         'Gollwitzer, Matthew'
Subject:                 CBER information request for STN 125408 (Flucelvax)
 
Importance:           High
Dear Mr. Gollwitzer-
 
Our review of STN 125408 (Flucelvax) is ongoing. Please provide a narrative report for study V58P13 Subject 05/390. To expedite our review, you may provide your response via e-mail. Please respond no later than August 17.
 
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
 
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