
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

 

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