
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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