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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, October 21, 2011 - Flublok

 

Submission Type: BLA    Submission ID: 125285/0    Office: OVRR
Product:
Influenza Vaccine
Applicant:
Protein Sciences Corporation
Telecon Date/Time: 21-Oct-2011 01:35 PM        Initiated by FDA? Yes
Telephone Number: E-mail
Communication Categorie(s):
1. Information Request
Author: TIMOTHY FRITZ
Telecon Summary:
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
Telecon Body:
From:                    Fritz, Timothy
Sent:                      Friday, October 21, 2011 1:59 PM
To:                         Penny Post (penny.post@proteinsciences.com)
Subject:                 CBER Information Request for STN 125285 (FluBlok)
 
Importance:           High
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.
 
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
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