• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu

Vaccines

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
 
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify the sender immediately by e-mail or phone.