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Vaccines, Blood & Biologics

Record of Telephone Conversation, November 21, 2012 - 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: 21-Nov-2012 01:30 PM Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
1. Advice


Telecon Summary:
Telephone conversation regarding the approach to revise pertinent sections of the BLA since GSK is going to remove information pertaining to the use of ----(b)(4)----------------------- from the BLA.

FDA Participants: Carmen M. Collazo-Custodio, Gale Heavner, Jeremy Wally

Non-FDA Participants: Michael Schwartz

Reference is made to CBER’s requests for information (dated October 17, 2012, and November 8, 2012) regarding the use of (b)(4) AS03 final container filling methods (-----------------(b)(4)-----------------------------) and the need for a container closure integrity test (CCIT) sufficiently sensitive to ------(b)(4)------. CBER also requested data to support that the level of ---(b)(4)---------- meets the acceptance limits throughout the shelf-life of the product, which could be determined as part of the stability program through CCIT testing at the last time point.

As a result of these requests, GSK changed its position and decided to seek approval only for filling the AS03 final container (10-dose glass vial) under ----(b)(4)-------------------. Therefore, they will no longer seek approval for ----------(b)(4)------------------------------------------.

Telecon Body:

GSK asked whether a cover letter submitted in a BLA amendment would be sufficient to capture this change in position. Also discussed was the possibility of revising the BLA by removing information pertaining to the ------------(b)(4)---------------------------- from the application.

CBER recommended the following to GSK to facilitate ease of review:

  1. To provide a cover letter detailing the changes made to the application.
  2. 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 was to replace or delete relevant sections of the XML file.
  3. 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.).
  4. To provide clean documents and versions with “track changes” of each revised section.

GSK agreed to update the BLA by deleting or replacing information pertaining to the ---------------(b)(4)------------------------ from the application to accurately reflect what they are seeking for approval. A cover letter detailing the changes made to the application, a table, and clean as well as ‘tracked changes” version of the documents will be included to facilitate review by CBER.

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