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Vaccines, Blood & Biologics

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
Communication Categorie(s):
1. Information Request
Telecon Summary:
-(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
Telecon Body:
From:                    Fritz, Timothy
Sent:                      Friday, September 28, 2012 4:34 PM
To:                         'Gollwitzer, Matthew'
Subject:                 CBER Information Request for STN 125408 (Flucelvax)
Importance:           High
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.
Thank you.
Timothy A. Fritz, Ph.D.
WOC2 HFM-478
1451 Rockville Pike
Rockville, MD 20852
Phone: 301-796-2640
Fax: 301-827-1597
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Page Last Updated: 12/19/2012
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