FACSIMILE TRANSMISSION RECORD
Division of Blood Applications
1401 Rockville Pike, Suite 400N, HFM-380
Rockville, Maryland 20852-1448
FAX (301) 827-2857
TEL (301) 827-3524
FAX No. 919-881-0014
To: W.Gerald Coln, Carolina Research on behalf of Fresenius Kabi
Information Request for STN: BN070012
The review committee for STN: BN070012 requests response to the following question in the form of an amendment to the file by COB 11-Sep-2007 in order to continue the review.
- Please describe how you computed the estimate and confidence intervals for Factor VIII and vWB levels presented in table 4 of your SBA.
If you need clarification please call me at 301-827-6165
Franklin T. Stephenson
Regulatory Project Manager
Information provided by: F. Stephenson Date: 9/4/2007
Approved by L. Landow Date 8/30/2007 Transmitted by F. Stephenson Date: 9/4/2007