
Record of Telephone Conversation, June 27, 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: 27-Jun-2012 04:19 PM        Initiated by FDA? Yes

Telephone Number: Communicated via e-mail

Communication Categorie(s):

1. Information Request

Author: TIMOTHY FRITZ

Telecon Summary:

Trivalent bulk in-process sterility testing clarification

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, June 27, 2012 4:19 PM

To:                         'Gollwitzer, Matthew'

Subject:                 CBER Information Request for Novartis STN 125408

 

Importance:           High

Dear Mr. Gollwitzer-

 

We are working on responses to the questions posed in your May 25, 2012 e-mail. Before we can provide an answer to Question 3, we will need you to respond to the following question:

 

CBER observed that you perform sterility tests as "In-Process Controls" at the Final Trivalent Bulk -----------------------------(b)(4)---------------------------------------------------- (Sections 3.2.P.3.4.1.1 and 3.2.P.3.4.1.2). Considering these sterility tests are performed on formulated trivalent bulk, please explain the reason(s) for not classifying this bulk as sterile. Please also clarify the difference between the IPC sterility test and a release sterility test.

 

You may respond to this request via e-mail to shorten the time needed for our response. 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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