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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Mid-Cycle Meeting Minutes Memorandum - Hizentra, September 30, 2009


Date:      September 30, 2009         

From:     Pratibha Rana

To:        STN 125350/0

Re:        Mid-Cycle Meeting Minutes 

Date: September 29, 2009

Location: WOC, 400N

Time: 10:30 am-11:30am

Attendees: Pei Zhang, Nisha Jain, Hun-Sum Ko, Iftekhar Mahmood, Evi Struble, Dot Scott, Jessica Kim, Jiang Hu, Robert Fisher, Pratibha Rana, Maria Luisa Virata Theimer
Attendees (via phone): Bhanu Kannan, Joe Quander, Lisa Stockbridge

  1. There were no major issues noted at this time for all disciplines.
  2. CMC needs some clarification regarding product specification for appearance. Maria will include letter ready comments in her memo.
  3. Bhanu updated the team that Bimo inspection of two sites has been issued.
  4. The review committee was reminded to enter the mid-cycle if it has been completed already.