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AABB > Press Room > Correspondence

Follow up to the Letter from AABB Bacterial Contamination Standard Task Force to Gambro BCT and Fenwal in Response to the Discontinuation of the Passport Study – 2/13/08 

February 13, 2008

 

 

Jaroslav Vostal, Laboratory Chief

Division of Hematology, OBRR, CBER

 

Dear Dr. Vostal,

 

In previous communication to PASSPORT study sponsors (dated January 31, 2008) that was shared with your office the data from PASSPORT cited is as yet unvalidated by the study sponsors and should not have been quoted.  I apologize for this error, and look forward to the opportunity to review updated data when it has been validated.

 

Sincerely,

 

Louis M. Katz, Chair

AABB Bacterial Contamination Task Force

 

CC          Jesse Goodman, Director

                Center for Biologics Evaluation and Research

 

                Jay Epstein, Director

                Office of Blood Research and Review, CBER

 

                Ron K. Labrum

                Chief Executive Officer, Fenwal Blood Technologies

               

                David Perez

                President, Gambro BCT

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