FDA proposes electronic safety reporting
The Food and Drug Administration is looking to beef up its postmarket surveillance capabilities by requiring drug- and devicemakers to report adverse events in an electronic format. Currently, most reports are filed on paper then entered manually into the agency’s computer system.
A pilot program in place since 2000 has allowed for electronic reporting, but the FDA in August proposed rules that would force manufacturers, packers and distributors to submit reports electronically. The proposed rules do not apply to reports submitted on a voluntary basis or for reports filed under an investigational new drug application.
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