Record of Telephone Conversation, December 14, 2012 - Flublok
Submission Type: BLA Submission ID: 125285/0 Office: OVRR
Protein Sciences Corporation
Telecon Date/Time: 14-Dec-2012 03:35 PM Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
2. Information Request
Author: TIMOTHY FRITZ
RT investigation summary, Flublok shelf life
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Friday, December 14, 2012 3:35 PM
To: 'Penny Post'
Subject: CBER advice/information request for STN 125285 (Flublok)
Attachments: CBER advice information request STN 125285.pdf
Dear Dr. Post-
Our review of Protein Sciences Corporation's Flublok Biologics License Application (STN 125285) is ongoing. We have the following advice and request for additional information:
1. CBER does not agree to an extension of the Flublok shelf life. When available, CBER recommends submission of data that provides a statistically valid assessment of stability, as described in Krause, 2009 (Biologicals 37: 369-378), with data from product manufactured over several seasons to support extension of shelf life.
a. PSC should provide a statistical analysis to support the number of product lots used, and a scientific rationale for the number of seasons examined.
b. In the model presented for determining shelf life, the lowest release limit (LRL) of –b(4)----- should be used at the onset of the dating period, and the Lower Limit (LL) of –b(4)-------- can be used to determine shelf life when assay and regression slope precision are taken into consideration. Assay variability must be considered as a factor in your calculation of shelf life.
c. When submitting stability data, the number of vials tested to generate the potency value and the % RSD acceptance criterion should be noted.
d. In previous submissions, you described the biphasic nature of monovalent bulk decay. Since this could contribute to the differences in H3 and B decay slopes for product lots –b(4)---------------------------------, please consider this when planning your future studies to extend product shelf life.
2. We acknowledge your July 16, 2012, submission (Amendment 57) in which a summary of your –b(4)---------------------------------- investigations to that date was provided. Please provide an updated, complete summary of all of PSC's investigations of the –b(4)--------, the results obtained, the conclusions reached, and a discussion of why PSC believes the –b(4)-------- does not pose any risk.
Please provide your response as an amendment to STN 125285 as soon as possible. If you have any questions, please contact the Regulatory Project Chair, Dr. Timothy Fritz, at 301-796-2640.
Timothy A. Fritz, Ph.D.
1451 Rockville Pike
Rockville, MD 20852
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