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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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FACSIMILE TRANSMISSION RECORD, October 21. 2010 - Corifact

FACSIMILE TRANSMISSION RECORD
Division of Blood Applications
1401 Rockville Pike, Suite 400N, HFM-380
Rockville, Maryland 20852-1448

FAX  (301) 827-2857
TEL  (301) 827-3524

 

FAX No.   610-878-4182
To:  David Desris, PharmD, CSL Behring, LLC
From:  Nannette Cagungun, OBRR/CBER/FDA
Date:  October 21, 2010

Re:  STN 125385/0

We are reviewing your August 18, 2010 BLA submission for Factor XIII Concentrate (Human) for the routine prophylactic treatment of congenital FXIII deficiency.  We determined that the following information is necessary to continue our review:

  1. Please submit 5 samples each of the conformance lots ---------------------------(b)(4)------------- to the following address:

    Sample Custodian (ATTN:  HFM-672)           
    Center for Biologics Evaluation and Research   
    Bldg: NLRC-B, Room:  113    
    5516 Nicholson Lane  
    Kensington, Maryland  20895                                      

    The samples should be accompanied by a Letter for Licensing Sample Submission, and their respective Lot Release Protocols.  Templates of the Letter and Lot Release Protocol are enclosed for your reference.

     
  2. Please submit individual Case Report Forms (CRF) in PDF file format for all subjects in the pivotal study BI71_023_2002.

The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission.  Please submit your response to this information request as an amendment to the BLA by October 28, 2010.  If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified. 

If you have any questions, please contact me at (301) 827-6174.

Sincerely yours,

Nannette Cagungun
Regulatory Project Manager
DBA/OBRR/CBER/FDA
Tel: (301) 827-6174