Regulatory News In Brief

FDA's $2.5 billion IT fix: FDA will spend up to $2.5 billion to improve its information technology and data center management services over the next ten years, the agency announced Sept. 30. FDA selected ten contractors based in Maryland or Virginia to carry out its IT modernization program. Task orders have already been awarded to IT Solutions, Buccaneer and EDS to design and migrate all systems applications to two new data centers. FDA's device center stresses the importance of moving away from paper-based systems, supporting pre- and post-market transformation efforts including electronic adverse event reporting, electronic copies of application submissions and, eventually, fully electronic pre-market submissions, starting in the diagnostics office and eventually to be adopted throughout CDRH. Critics have blamed FDA's flawed IT infrastructure in part for emerging medical product safety issues (1"The Gray Sheet" Feb. 4, 2008, p. 4)