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U.S. Department of Health and Human Services

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
Time: 3:00-4:00pm
 
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
  • Yes
 
3.     Indentify if consult review is needed
  • None at this time
 
4.     Notify OBRR PeRC Representative:
  • Yes, Nisha has been notified.
 
5.     Inspections Needed?
  • Yes
 
6.     BPAC eligible?
  •  No
 
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.