
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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