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Vaccines, Blood & Biologics

Record of Telephone Conversation, February 11, 2013 - Q-Pan

Submission Type: BLA

Submission ID: 125419/0

Office: OVRR

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

ID Biomedical Corporation of Quebec (dba GlaxoSmithKline Biologicals)

Telecon Date/Time: 11-Feb-2013 12:31 PM Initiated by FDA? No

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Other - GSK response to CBER comments of Feb. 8, 2013


Telecon Summary:
GSK decided to remove the information submitted in the BLA regarding the use of –b(4)--------------------- for storage of the –b(4)------------- in response to CBER’s comments provided on February 8, 2013. Due to GSK’s decision, a conference call scheduled for February 8, 2013, at 2:00 PM was cancelled since the matter was resolved and there was no need for further discussion.

FDA Participants: Carmen Collazo-Custodio

Non-FDA Participants: Michael Schwartz

From: Michael Schwartz []
Sent: Monday, February 11, 2013 12:31 PM
To: Collazo, Carmen
Subject: --b(4)---------- - withdraw from BLA

Dear Carmen,

Due to the CBER comments and concerns with the use of –b(4)-------------for storage of -b(4) we have decided to withdraw their use from the BLA.

  • --b(4)---- has discontinued the—b(4)-------
  • GSK does not plan to use these –b(4)---- in the future (since –b(4)---- has discontinued them)
  • Only a small amount of ----b(4)-------------) is stored in –b(4)------------- as part of the stockpile
  • The small amount in –b(4)------- is approaching –b(4)------- of age (late 2013), expiry

If GSK chooses to pursue the use of this small volume of –b(4) in the stockpile we will submit for licensure of the –b(4)------- as a post approval submission.

Kind Regards,


Michael P. Schwartz, PhD
U.S. Regulatory Affairs - Adjuvanted Influenza Vaccines

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