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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Meeting Minutes, December 22, 2010 - Bivigam

 

Date:         December 22, 2010                                 
 
From:        Pratibha Rana
 
To:             STN 125389/0
 
Re:             Filing Meeting Minutes
________________________________________________________________________
 
Few of us called in and cancelled the filing meeting scheduled for December 16, 2010. All the reviewers notified via email memos for the filing meeting.
 
The purpose of this meeting:
 
  1. If this BLA application is fileable
    • Yes. From all the disciplines.
 
  1. If there are any deficiencies
  •  There were no deficiencies identified.
 
  1. CRB assess applicants PREA Recommendation, Contact PREA rep.
  • Mitch and I met with Nisha and the following request was sent to the Sponsor as per Mitch’s request.
 
Please submit pediatric waiver/deferral to the BLA. Please request a waiver for < 2 years and a deferral for 2 to 16 years and provide a reason for the waiver and deferral.
 
For the deferral group, also submit a pediatric plan with the type of study, the date it will begin and the date it will be completed. The study should include PK, safety and efficacy. Generally these studies have had 20 subjects with the numbers spread evenly across the 2 to 16 year ages.
 
  1. Telecon Date determined fro PMC, PMR, Labeling
  • Telecon is scheduled for August 2, 2010.