Record of Telephone Conversation, October 21, 2011 - Flublok
Submission Type: BLA Submission ID: 125285/0 Office: OVRR
Protein Sciences Corporation
Telecon Date/Time: 21-Oct-2011 01:35 PM Initiated by FDA? Yes
Telephone Number: E-mail
1. Information Request
Author: TIMOTHY FRITZ
SRID –b(4)------ data for B strains and process validation 4 (PV4) strains.
FDA Participants: Timothy Fritz
Non-FDA Participants: Penny Post
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Friday, October 21, 2011 1:59 PM
To: Penny Post (firstname.lastname@example.org)
Subject: CBER Information Request for STN 125285 (FluBlok)
Dear Dr. Post-
Prior to providing advice regarding Protein Sciences Corporation's next fill validation runs, CBER requests that PSC submit the SRID –b(4)----- concentrations determined at time of manufacture for all B/Brisbane/60/2008 monovalent bulk drug substance lots produced to date, and the SRID -b(4)--- concentrations for lots used in fill validation PV4 (A/California/09 lots ----b(4)-------------------------- A/Perth/09 –b(4)-----; B/Brisbane/08 –b(4)------------------) at the time of fill. Please provide these data as an amendment to STN 125285.
If you have any questions, please contact the Regulatory Project Manager, Dr. Timothy Fritz, at 301-796-2640.
Timothy A. Fritz, Ph.D.
1451 Rockville Pike
Rockville, MD 20852
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