An ISO 13485:2003, 9001:2000 Registered Company
BIO/DATA CORPORATION
Drug Agency Mandated Programs

On September 27, 2007, President Bush signed into law H.R. 3580, the Food and Drug
Administration Amendments Act of 2007 (FDAAA). The FDAAA constitutes the most



The new regulations indicate platelet function studies are now required for drugs that are
designed for cardiovascular, biological, diabetic and antiplatelet drugs or for
therapeutics’ such as Factor VIII and von Willebrand Factor.
CLINICAL RESEARCH TRIALS
An ISO 13485:2003, 9001:2000 Registered Company
155 Gibraltar Road, PO Box 347, Horsham, PA 19044-0347 USA
(215) 441-4000 Worldwide / (800) 257-3282 USA / (215) 443-8820 Fax Worldwide
Website: www.biodatacorp.com / Email:  
customer.service@biodatacorp.com
© BIO/DATA CORPORATION 2008. All Rights Reserved.