FDA TO REVAMP SAFETY DATA SYSTEM

AUGUST 01, 2006

FDA officials are hoping to have a common Webbased system to collect safety data about drugs and medical devices within 2 years. The project would merge and automate the individual, laborintensive systems run by various centers that make up the FDA.

The agency requires manufacturers to report adverse drug events (eg, potential safety issues) associated with the use of their products. Currently, those reports now come into the FDA in both electronic and paper formats. Once received, they are sorted and rerouted by hand. The new system would accept the reports electronically, then automatically add preliminary analysis and context before rerouting them to the correct center for attention, explained Scott Gottlieb, MD, FDA's deputy commissioner for scientific and medical affairs.

The data allow the FDA to identify and act on possible safety concerns about medications and devices that already are available. Lawmakers have urged the FDA to be more reactive to those concerns.




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