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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Official Meeting Summary Coverletter


Our Reference: CRMTS #7260                                              Division of Blood Applications
                          Ref #STN 125335/0                                  Telephone: (301) 827-3524
Instituto Bioclon, S.A. de C.V.
Attention: ----(b)(4)---------------
Dear ------(b)(4)-------:
Attached is a copy of the memorandum summarizing your November 18, 2009, Type C, meeting with CBER. Please note that although cited as attachments to the summary, we did not include copies of materials you supplied. This memorandum constitutes the official record of the meeting. If your understanding of the outcomes differs from those expressed in this meeting summary, it is your responsibility to bring these discrepancies to CBER’s attention for resolution.
If you have any questions, please contact Debbie Cordaro at 301-827-6157.
Sincerely yours, 
Jeffrey M. Anderson, M.S., RAC
Regulatory Project Management Branch
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research