Record of Telephone Conversation, September 28, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 28-Sep-2012 04:34 PM Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
1. Information Request
Author: TIMOTHY FRITZ
-(b)(4)- assay for BPL quantitation.
FDA Participants: Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Friday, September 28, 2012 4:34 PM
To: 'Gollwitzer, Matthew'
Subject: CBER Information Request for STN 125408 (Flucelvax)
Dear Mr. Gollwitzer-
Our review of Novartis' Flucelvax BLA submission (STN 125408) is ongoing. We have the following requests for additional information:
1. In the -(b)(4)- assay validation report for the measurement of residual -----(b)(4)-------- BPL, we noted that the sample matrix may exert some interference. For specificity testing, results for two of the three tested -----(b)(4)-------- showed that the --(b)(4)-- matrix substantially reduced BPL quantitation (see Table below comparing spiked sample to Blank 3 results). Please provide a justification for how this assay can be used for the measurement of residual BPL in the -----(b)(4)-------- given this observed interference.
The Summary below is based on BPL limit test validation report V.03.REP.P141_01 (Fig 1-21) pg 11-13, submitted in Amendment 33.
2. Please provide validation data to demonstrate the accuracy and robustness of this assay.
3. Please elaborate on the importance of the Limit Test Performance in the System Suitability Test and explain how the acceptance criteria is being established.
Please submit the requested information as an amendment to STN 125408 as soon as possible. We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.
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.
Timothy A. Fritz, Ph.D.
1451 Rockville Pike
Rockville, MD 20852
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.