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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Team Meeting Agenda, March 15, 2013 - ALLOCORD

Sponsor:          SSM Cardinal Glennon Children’s Medical Center
BLA #:            BLA 125413
Product:          Hematopoietic Progenitor Cells
Date:               March 15, 2013
Time:              2-3 PM

 
1.         Status of Discipline Reviews/Issues Needing Resolution  
 
  • CMC – Brent, Joydeep, Safa, Brian
    Need ISBT 128 form
    Brent to have tcon re: acceptance criteria
    Working on SBRA
  • DMPQ –Nancy
  • Clinical – Lei – review done
  • Stats – Renee – review done
  • Labeling – Loan – working on PI
                       
2.         Timeline
      (Assuming a May 15 target approval date)
 
            March 4
            PNR letter due  (letter was sent March 1)
 
            March 20
            Draft Review Memos Due to TL/BC (Review Committee)
 
            April 3
            Draft Review Memos Due to DD (Review Committee)
            Draft SBRA memo (Review committee)
            Draft Approval Letter (RPM)
 
            April 17
            Final Review Memos Due to Office Director (Review Committee)
            PMC Study Target (tcon with applicant)
            Labeling Target (tcon with applicant)
 
Participants: Stephanie Simek, Safa Karandish, Ilan Irony, Keith Wonnacott, Lei Xu, Brian Niland, Loan Nguyen, Brent McCright, Kim Benton, Joydeep Ghosh, Renee Rees, Lori Tull