
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)--------

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

----------(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