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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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 PandeyCommittee ChairOVRR/DVRPA/VVB
Katherine BerkhousenRegulatory CoordinatorOVRR/DVRPA/VVB
Cynthia NollettiMedical OfficerOVRR/DVRPA/CTB
Joe ToernerMedical OfficerOVRR/DVRPA/CTB
Galina VodeikoProduct ReviewOVRR/DVP/ LPRVD
Zhiping YeProduct ReviewOVRR/DVP/ LPRVD
Dale BurwenMedical OfficerOBE/DB/VSB
Bhanumathi KannanBioresearch MonitoringOCBQ/DIS/BMB
Catherine MillerLabeling/Product NameOCBQ/DCM/APLB
William McCormickProduct QualityOVRR/DPQ
Rajesh GuptaProduct QualityOVRR/DPQ/PQLS
Joseph Quander IIIProduct Release BranchOCBQ/DMPQ/PRB
Sue DoughertyProduct Release BranchOCBQ/DMPQ/PRB
Pete AminEstablishmentOCBQ/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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