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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Summary of Meeting Memorandum - Anascorp


Our Reference: CRMTS #7517                                               Division of Blood Applications
                     BL 125335/0                                                 Telephone: (301) 827-3524
Instituto Bioclon, S.A. de C.V.
Attention: ----------(b)(4)------------
C/O --------(b)(4)--------
Dear -----(b)(4)------:
Attached is a copy of the memorandum summarizing your July 15, 2010, 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, 
Alan E. Williams, Ph.D.
Associate Director for Regulatory Affairs
Acting Chief, Regulatory Project
 Management Branch
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research