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Vaccines, Blood & Biologics

Major Amendment Memo, February 20, 2013-Q-Pan H5N1


Public Health Service

Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448


February 20, 2013
Carmen M. Collazo-Custodio, Ph.D., Chair, BLA Review Committee
Elizabeth M. Sutkowski, Ph.D., Branch Chief, Regulatory Review Branch III
File, STN 125419
Designation of November 30, 2012, submission as a major amendment
ID Biomedical Corporation of Quebec [dba GlaxoSmithKline Biologicals (GSK)]

This memo is to communicate to the file that an amendment received on November 30, 2012, was designated as a major amendment.

On December 6, 2012, Dr. Marion Gruber informed GSK of a decision made to designate an amendment received on November 30, 2012, as a major amendment (refer to the Record of Telephone Conversation dated December 6, 2012). Dr. Gruber explained that a substantial amount of information was submitted on November 30, 2012, that needed to be adequately reviewed in a limited amount of time, given the Action Due Date of December 22, 2012. A Major Amendment Acknowledgement Letter was issued to GSK on December 13, 2012, to inform the Applicant of the new Action Due Date of March 23, 2013.

Status Update of STN 125419/0 as of December 5, 2012

  1. Two amendments arrived late in the review cycle (Amendments # 18 and # 19). These amendments were received on Friday, November 30, 2012.

    1. Amendment # 18 provided responses to CBER Information Requests of October 17 and November 8, 2012, and included changes to eCTD modules 2 and 3. These changes were made because GSK decided to seek approval (b)(4) for filling the AS03 final container under Class ---------------------------------(b)(4)----------------------- under the BLA for ---------------(b)(4)-----------). GSK stated that they are ------------------------------------(b)(4)-------------------------------------------------------- (approval of (b)(4) of these methods was originally requested, but GSK has not conducted adequate testing for filling under ---(b)(4)--). This decision was made in response to previous CBER Information Requests dated September 10, 2012, October 17, 2012, and November 8, 2012. A table was provided in the submission to facilitate review of these sections; however, review of these documents was going to be time consuming. The information provided in this amendment required that the Facilities and Product/CMC reviewers update their reviews.
    2. Amendment # 19 provided responses to CBER Information Requests of November 5, 19, 20 and 29, 2012. The information contained in this submission required CMC, Clinical, and Statistical reviewers to update their reviews. Additionally, this amendment included changes to the Lot Release Protocol (LRP) template, which required review and generated an additional comment to the Applicant from the Product Quality reviewers. Thus, the LRP template was not finalized.
  2. Additionally, as of December, 6, 2012, there were five pending Information Requests (including one that emerged on December 5, 2012, after a conference call held between CBER and GSK). These Information Requests were related to facilities information. During the conference call held on December 5, 2012, GSK acknowledged that they made several mistakes in the reports provided in the BLA (e.g., missing validation data, discrepancy in dates, incomplete summary reports). These reports were translations of reports originally in French, and because the translations contained inaccuracies, their review has been difficult.
  3. Regarding the Labeling review, CBER’s review comments on the PI and carton/container labels were provided to GSK on November 9, 2012. GSK submitted a revised PI on December 4, 2012, and proposed to submit revised carton/container labels on December 6, 2012.

Both amendments were important to CBER’s decision for a major amendment designation since the submissions contained multiple updates to the BLA, which would require significant review time. This decision was made based on the totality of the information submitted on November 30, 2012, as well as significant pending information. The review management team and OVRR management agreed that, for all of these reasons, it was not possible for a thorough review to be completed by December 22, 2012.

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