
Official Meeting Summary Coverletter - Anascorp

 
 

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)---------------

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----------(b)(4)--------------

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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 CBERs attention for resolution. 

 

If you have any questions, please contact Debbie Cordaro at 301-827-6157.

 

Sincerely yours, 

 

Jeffrey M. Anderson, M.S., RAC

Chief

Regulatory Project Management Branch

Division of Blood Applications

Office of Blood Research and Review

Center for Biologics

 Evaluation and Research