Monday, August 25, 2008 12:04 PM
|Subject:||STN.125317/0.CSL Behring. Human Fibrinogen Concentrate, Pasteurized. Riastap|
The reviewer for labeling portion of the BLA would like you to provide the "Rationale for Choice of Proprietary Name".
She mentioned that a review of the study report does not include the rationale for choice of the name, RIASTAP.
So, could you please provide that to us? If you think it is already included in one of the modules, could you please specify the location?
Vasantha Kumar, M.S., Ph.D.
1401 Rockville Pike
Rockville, MD 20852