Vaccines, Blood & Biologics
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First Committee Meeting Minutes, December 22, 2012 - Bivigam
Date: December 22, 2010
From: Pratibha Rana
To: STN 125389/0
Re: First Committee Meeting Minutes
Date November 23, 2010
Location: WOC -1
Attendees: Michael Kennedy, Harold Boxenbaum, Mitchell M Frost, Lillian Ortega, Alan C Ou, Evi Struble, Lilin Zhong, Douglas Frazier, Maria Luisa Virata, Malgorzata Mikolajczyk, Pei Zhang, Jessica Kim, Sonday Kelly, and Pratibha Rana
I updated the review team of the review schedule. I also notified that the Sponsor was requested to submit the entire PNR request to the BLA.
The purpose of this meeting:
1. Ensure submission is complete
- Yes. There were no issues noted from for all disciplines.
2. Ensure a reviewer is assigned
3. Indentify if consult review is needed
- None at this time
4. Notify OBRR PeRC Representative:
- Yes, Nisha has been notified.
5. Inspections Needed?
6. BPAC eligible?
7. Identify follow up activities to be completed before the filing meeting
- None at this time. Also as follow up, Michael Kennedy ( SL) will let me know if any other activity is missing.