From: Jessica Oldham [joldham@bio.org]
Sent: Wednesday, January 05, 2005 4:47 PM
To: Dockets, FDA
Subject: BIO comments to docket #2004D-0440; "Draft Guidance on Computerized Systems used in Clinical Trials" 

Please find attached the Biotechnology Industry Organization’s comments to “Draft Guidance on Computerized Systems Used in Clinical Trials.” (Docket No. 2004D-0440).  

 

Thank you, 

 

 

Jessica S. Oldham

Assistant, Science and Regulatory Affairs

Biotechnology Industry Organization

1225 Eye Street, N.W., Suite 400

Washington, D.C. 20005

Phone: (202) 962-9218

joldham@bio.org