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Vaccines, Blood & Biologics

Committee Meeting Memorandum

MEMORANDUM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

COMMITTEE MEETING FOR
STN 125254/0 CSL Ltd. ACN, Australia

STN 125254/0: CTD for Influenza Virus Vaccine

DATE: September 5, 2007

COMMITTEE MEMBERS PRESENT:

Rakesh Pandey
Committee Chair
OVRR/DVRPA/VVB
Katherine Berkhousen
Regulatory Coordinator
OVRR/DVRPA/VVB
Cynthia Nolletti
Medical Officer
OVRR/DVRPA/CTB
Joe Toerner
Medical Officer
OVRR/DVRPA/CTB
Galina Vodeiko
Product Review
OVRR/DVP/ LPRVD
Zhiping Ye
Product Review
OVRR/DVP/ LPRVD
Dale Burwen
Medical Officer
OBE/DB/VSB
Bhanumathi Kannan
Bioresearch Monitoring
OCBQ/DIS/BMB
Catherine Miller
Labeling/Product Name
OCBQ/DCM/APLB
William McCormick
Product Quality
OVRR/DPQ
Rajesh Gupta
Product Quality
OVRR/DPQ/PQLS
Joseph Quander III
Product Release Branch
OCBQ/DMPQ/PRB
Sue Dougherty
Product Release Branch
OCBQ/DMPQ/PRB
Pete Amin
Establishment
OCBQ/DMPQ/BII

SUMMARY:

Meeting was held to assess the pending review process of this application and to identify any outstanding concerns or reviewer needs.

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1
PAGE(S)
DETERMINED
TO BE
NOT RELEASABLE


Facilities/Establishment

  1. There are no major issues to prevent approval of this BLA related to inspection of the Parkville, Australia and ----------------------- facilities. DMPQ staff states that they will take care of the FONSI, lot release request, and compliance checks.

    BIMO

  2. The BIMO review is completed. The review is based on full inspection reports received from the Duke University site and the New Orleans site and email/verbal discussions from the Stanford University site inspector. There are no issues with the bioresearch monitoring inspections that would prevent licensing.

    Clinical

  3. The post marketing commitment study is under review and the details of the post marketing commitments are being evaluated. The package insert is on its second revision. CBER is waiting to hear back from CSL.
  4. CSL has requested a waiver from conducting a study(s) using their influenza virus vaccine in birth through six months of age pediatric patients. In addition, CSL is requesting a deferral from evaluating their influenza virus vaccine in the greater than six months to eighteen years of age pediatric population until CBER approves the data from the confirmatory post-marketing clinical endpoint study and a full label claim is granted. Their request is found in Module 1, Section 1.3.1.6.

    Labeling:

  5. Container and Carton review was completed and CSL was given a go ahead to print those for use. We had sent them comments of the PI and their revised PI was expected to come back to CBER by Septemeber 7th.

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