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
VIA EMAIL
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