FDA, MIT to Create New Safety Monitoring Devices
The Food and Drug Administration ("FDA") recently announced that it entered into an agreement with the Massachusetts Institute of Technology to develop a new safety monitoring system designed to more quickly identify problems with drugs and medical devices. The Associated Press reports that this new system will "scour federal and private health care databases in real time for unusual and emerging patterns that could indicate potential safety concerns." In further attempt to improve patient safety, the FDA also intends to regularly issue reports to physicians that inform them of potential risks associated with drugs and devices.
Currently, the FDA manually assesses reports submitted voluntarily. The FDA has stated that this safety monitoring system leaves many known problems unreported.