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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Record of Telephone Conversation, May 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-May-2012 03:49 PM        Initiated by FDA? Yes
 
Telephone Number: Conveyed via e-mail
Communication Categorie(s):
1. Information Request
 
Author: TIMOTHY FRITZ
 
Telecon Summary:
Audit report for Site 01, study V58P9 if available.
 
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:                      Wednesday, May 09, 2012 3:49 PM
To:                         'Gollwitzer, Matthew'
Subject:                 CBER Information Request for STN 125408 (Optaflu)
 
Importance:           High
 
Dear Mr. Gollwitzer-
 
Our review of STN 125408 (Optaflu) is ongoing. Please clarify whether an audit of Site 01 (Vilnius University Hospital) for clinical lot consistency study V58P9 was conducted by Lithuanian authorities or Novartis. If so, please provide us with the audit report within the next two weeks.
 
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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