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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Meeting Minutes, February 24, 2011 - Hemacord

Sponsor:        New York Blood Center

BLA #:                        BLA 125397
Product:        Hematopoietic stem/progenitor cells, cord (HPC-C)
Date:               February 24, 2011
Time:              3:30 -4:30PM
 
Meeting Attendees:Thomas, Terrolyn; Witten, Celia; Simek, Stephanie; Bryan, Wilson; Sista, Ramani; Przepiorka, Donna; Nguyen, Loan; Stockbridge, Lisa; Heidaran, Mohammad; Wang, Gang; Hoque, Atm S.; Wonnacott, Keith; Quagraine, Mercy; Jordan, Carla; Cato, Dennis; Karandish, Safa; Riggins, Patrick; Benton, Kimberly; Bross, Peter; Hyde, John E; Fan, Yong; Ou, Alan C.; Rees, Renee; Irons, Bennett; McCright, Brenton; Anatol, Rachael;
 
 
  1. Important dates:
    • Filing Letter Comments DueCOB, February 28, 2011 (The team agreed to include filing comments in the Day 60 filing letter)
    • Filing Letter Finalized: March 11, 2011
  2. Overview of Application by Discipline: Studies/info submitted; identification of Info Requests; Day 74 letter items
    The review team reached an agreement to file the BLA and stated whether or not they had letter comments for the Day 60 filing letter.
    • CMC - M. Quagraine; S. Karandish /  no filing issues and letter comments
    • DMPQ – M. Heidaran & G. Wang/ no filing issues and letter comments
    • Pharm/tox –  A. Hoque/no filing issues and no letter comments
    • Clinical – D. Przepiorka & J. Hyde /no filiing issues and letter comments
    • Stats – Rees, Renee /no filing issues and letter comments
    • Labeling – L. Stockbridge & L. Nguyen / no filing issues and letter comments
    • Epidemiology – A. Ou/ no filing issues and letter comments
    • BIMO - C. Jordan & D. Cato / The clinical reviewer stated that since there is no clinical trial; there is nothing for BIMO to inspect.  
  3. Identification of RTF Issues by Discipline
    No RTF issues were identified.
  4. Action Items
    • Request CDER consult for clinical team
    • Rachel Antol agreed to put BLA on SWAG calendar
    • Possible telecon with sponsor to discuss Donor Eligibility
    • Patrick Riggins will send email address for E-room.
    • Fix roadmap links in EDR
    • AC Meeting – Stephanie Simek is waiting for feedback.