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