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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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First Committee Meeting Minutes - Hizentra, May 18, 2009


Date:      May 18, 2009          

From:     Pratibha Rana

To:        STN 125350/0

Re:        First Committee Meeting Minutes

Date: May 18, 2009

Attendees: Iftekhar Mahmood, Pei Zhang, Jiang Hu, Sarah Tanksley, Bhanui Kannan, Hon Sum Ko, Joseph Quander, Luisa Maria Virata, Evi Struble, Deborah Trout, Lisa Stockbridge, Pratibha Rana

The purpose and the outcome of this meeting are presented below:

  • To ensure the submission is complete.
    The submission was accepted to be complete.
  • To ensure a reviewer is assigned to review each section of the supplement.
    Reviewers from each discipline have been assigned.
  • To identify if consult reviewers are needed in the review process.
    Consultant reviewers not required at this time.
  • To identify follow up activities to be completed before the next meeting (Filing Meeting).
    The Filing Meeting is scheduled for June 11, 2009.
  • To share the review findings to date and advice if there are any actions required at this time.
    No action required at this time.
  • To advise if others need to be included in this review.
    No other reviewer was found necessary at this point of time.