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www.fdanews.com/articles/62216-fda-partners-with-mit-to-develop-device-tracking-database

FDA PARTNERS WITH MIT TO DEVELOP DEVICE-TRACKING DATABASE

September 1, 2006

The FDA is partnering with the Massachusetts Institute of Technology (MIT) to develop new databases to monitor devices and drugs after they have been approved.

MIT's Center for Biomedical Innovation (CBI) will help the agency supplement its current safety data with automated healthcare databases. MIT said its computerized system will analyze data on device and prescription drug use to detect dangerous side effects more quickly.

This will help address shortfalls in the current system, Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, told CBI members during an Aug. 17 meeting. "We need to improve the information we rely upon and our tools and resources for gathering that information in a timely and reliable way," he added.

"Our goal through this collaborative effort (with the FDA) is to rapidly respond to signals that we find, while balancing the need for scientifically rigorous analysis with sensitive and timely detection of issues that may impact the public," said Frank Douglas, the CBI's executive director.

(http://www.fdanews.com/ddl/33_34/)