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FDA Head: We’re Boosting I.T.
April 24, 2008
Updating the Food and Drug Administration’s information systems is one of the top priorities in the agency, FDA Commissioner Andrew von Eschenbach, M.D., told Congress in recent testimony.
He spoke on April 22 before the House Energy and Commerce subcommittee on oversight and investigations, which is studying FDA actions to improve the safety of medical devices and products made with foreign components.
The FDA, von Eschenbach said, needs a modern I.T. infrastructure to better use data it already has and to better coordinate various activities within the agency. Existing information systems, for instance, do not have the capability to automatically verify information submitted by foreign firms that ship components of regulated products into the United States.
“FDA plans to enhance its I.T. systems in ways that will enable the agency to better utilize risk-based information from the entire life-cycle of imported products,” von Eschenbach testified. “Many of these improvements will be implemented in the next two years; implementation of a few will extend beyond 2010. These projects will improve databases, enhance interoperability of systems within the agency and among other regulatory agencies, and provide better analytical function to assess and control risk.”
For full text of the testimony, which covered a range of issues associated with foreign-made components of regulated products, click here.
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