
Meeting Summary Cover Letter - Isoplate Solution

 

 

Our Reference: CRMTS #8012                                              Division of Blood Applications

                         Ref. # BN090067                                          Telephone: (301) 827-3524

 

 

B. Braun Medical Inc.

Attention: Rebecca A. Stolarick

901 Marcon Boulevard

Allentown, PA 18109

 

Dear Ms. Stolarick:

 

Attached is a copy of the memorandum summarizing your June 30, 2011 Type A meeting with CBER. 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 Iliana Valencia, Regulatory Project Manager, at (301) 827- 6161.

 

Sincerely yours, 

 

 

 /s/

 

 

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