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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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9/4/2007 Fax

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.

 

  1. 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

Thanks,

Franklin T. Stephenson
Regulatory Project Manager
FDA/CBER/DBA/OBRR/RPMB


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