
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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