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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, May 26, 2011 - Laviv

Submission Type: BLA    Submission ID: 125348/0    Office: OCTGT

  Product:
  Autologous Cultured Fibroblasts

  Applicant:
  Fibrocell Technologies, Inc.

  Telecon Date/Time: 26-May-2011  11:00 AM        Initiated by FDA? Yes

  Telephone Number:
  Communication Categorie(s):

  1. Information Request
 
  Author: DONALD FINK JR.
  Telecon Summary:

  Discussion regarding ------(b)(4)------

Topic: CMC Post-marketing Commitment /  LaViv / BLA STN BL 125348

FDA Participants:
  Keith Wonnacott, Ph.D.  / Branch Chief / CTB-DCGT-OCTGT
  Kim Benton, Ph.D. /  Deputy Director / DCGT-OCTGT
Donald Fink, Ph.D. /  Consult CMC Reviewer / CTB-DCGT-OCTGT

Sponsor:
  Dana Weinberger, Ph.D  / Sponsor Authorized Representative / CBR Intl Corp
  Jeanne Novak,  Ph.D. / CEO-President / CBR Intl Corp
  John Maslowski, M.S. /  VP-Operations, FIBROCELL
  Karen Donhauser, Ph.D.  / VP-Quality, FIBROCELL
  Kevin Hennegan, MA /  Senior Managing Consultant, CBR Intl Corp

---------------------------------------(b)(4)--------------------------------------------------------  licensed product, sponsor informed about alternative of ---------------(b)(4)---------------------------------------------------  data in an annual report to the BLA as a post-marketing commitment.  The  sponsor provided oral agreement to honor this commitment.

FDA asked sponsor,  FIBROCELL, to submit, in writing, its agreement to honor a post-marketing  commitment for submission of CMC information related to -----(b)(4)--------- in  Annual Reports to the BLA.  Information pertaining to the following is to  be provided:

     
  1. --------------------------------------------(b)(4)-----------------------------------------------------------------------------.  
  2. -------------------------------------------(b)(4)-----------------------------------------------------------------------------------  
  3. -------------------------------------------(b)(4)----------------------------------------------------------------------------------------------

Sponsor agreed to  submit, in writing and in an expedited manner, its agreement to honor the CMC  post-marketing commitment outlined.