The FDA wants to amend its postmarket safety reporting regulations to mandate that drug and device manufacturers and other reporters file adverse incident reports in an electronic format. This will, according to the agency, increase the ease with which it can file and archive the reports. Under the current system, most adverse event reports are submitted on paper, requiring the extra step of someone manually inputting the data into the adverse event database, called the Manufacturer and User Facility Device Experience (MAUDE) database, for further analysis. This adds to the costs of reporting and slows down the FDA's ability to identify problems with drugs or devices and take the appropriate actions. The two proposed rules — one pertaining to drugs and the other to medical devices — will, according to a statement from David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA's Center for Devices and Radiological Health (CDRH), "improve the agency's ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems."
"ELECTRONIC REPORTING BEING PUSHED." Medical Malpractice Law & Strategy 1 Oct. 2009. Academic OneFile. Web. 19 Nov. 2009.
Gale Document Number:A208744379
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