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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, November 29, 2012 - Q-Pan


Submission Type: BLA    Submission ID: 125419/0    Office: OVRR

Product:
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Applicant:
ID Biomedical Corporation of Quebec

Telecon Date/Time: 29-Nov-2012 10:35 AM        Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Information Request

Author: CARMEN COLLAZO-CUSTODIO

Telecon Summary:
Characterization of new working seed banks

FDA Participants: Jeremy Wally, Kirk Prutzman, Carmen Collazo-Custodio

 

Non-FDA Participants: Michael Schwartz, Robert Brobst, Jillian Horvath

Telecon Body:
The following IR was communicated to GSK via e-mail correspondence.


 

______________________________________________
From:                     Collazo, Carmen 
Sent:                      Thursday, November 29, 2012 10:35 AM
To:                          Michael Schwartz
Cc:                          Robert Brobst; Jillian Horvath; Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject:                STN 125419 - Information Request
Importance:        High

 

Dear Dr. Schwartz,

We have the following Information Request:

Consistent with CBER's policy for influenza virus vaccines, please revise your SOPP for characterization of new working seed banks, to include antigenic verification by CBER, and, therefore, provide all the future working seeds to CBER for verification of antigenic relatedness to the designated reference strains.

Regards,

Carmen M. Collazo-Custodio, Ph.D.
Microbiologist
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
WOC2 RM2236 HFM-481
1451 Rockville Pike
Rockville, MD 20852

Tel. 301-796-2640
Fax: 301-827-3532
E-mail address: carmen.collazo@fda.hhs.gov