Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
ID Biomedical Corporation of Quebec
Telecon Date/Time: 12-Feb-2013 08:56 AM Initiated by FDA? Yes
Telephone Number: 610-787-3435
Author: CARMEN COLLAZO-CUSTODIO
CBER recommended updating the BLA by deleting or replacing information pertaining to the –b(4)-----------------. Advice was provided on how to submit this information to facilitate review of the submission.
FDA Participants: Jeremy Wally, Kirk Prutzman, Carmen Collazo-Custodio
Non-FDA Participants: Michael Schwartz
The following was communicated to GSK via e-mail correspondence:
From: Collazo, Carmen
Sent: Tuesday, February 12, 2013 8:56 AM
To: 'Michael Schwartz'
Cc: Wally, Jeremy; Prutzman, Kirk C; Collazo, Carmen
Subject: RE: ---b(4)------- - withdraw from BLA
Thank you for this update. Should you choose to pursue the use of the H5N1 –b(4)------------------ stored in ---b(4)---- as part of the stockpile and, therefore, submit a post-approval supplement for the use of these –b(4)-, we remind you that you will need to provide complete leachables and stability data before use of H5N1 –b(4) stored in the –b(4)--------
Also, we refer you to the telephone conversation of 21-Nov-2012 in which we discussed the approach to revise pertinent sections of the BLA since you decided to remove information pertaining to the use of –b(4)--------------------- from the BLA. During the teleconference, you agreed to update the BLA by deleting or replacing information pertaining to the –b(4)-------------- of the filled vial headspace from the application to accurately reflect what you are seeking for approval.
Using a similar approach, we recommend that you update the BLA by deleting or replacing information pertaining to the –b(4)----------- and provide this information as outlined below to facilitate our review:
- To include a cover letter detailing the changes made to the application and to provide a justification for removing this information from the BLA. In addition, please include in the cover letter your plans to submit a supplement post-approval should you decide to pursue the use of these –b(4) in the future.
- To update the eCTD by revising relevant sections of the BLA so that the application accurately captures what CBER is currently reviewing and, possibly, approving. (The approach suggested during the teleconference of 21-Nov-2012 was to replace or delete relevant sections of the XML file).
- To provide a table detailing the changes made to each of the sections in a particular module as well as to indicate the specific location of the changes (e.g., page number, document name, etc.).
- To provide clean documents and versions with “track changes” of each revised section.
Carmen M. Collazo-Custodio, Ph.D.
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
E-mail address: email@example.com
From: Michael Schwartz [mailto:firstname.lastname@example.org]
Sent: Monday, February 11, 2013 12:31 PM
To: Collazo, Carmen
Subject: --b(4)-------- - withdraw from BLA
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) years 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.
Michael P. Schwartz, PhD
U.S. Regulatory Affairs - Adjuvanted Influenza Vaccines