FDA to create new system for capturing adverse event reports
The Food and Drug Administration plans to streamline its system for collecting adverse event reports on medications and medical devices.The FDA wants to establish a new electronic system within two years. It would combine the five current systems and integrate parts of the current systems that use paper reports.
Scott Gottlieb, a deputy commissioner with the FDA, said the system will be user friendly to the general public. It also may allow physicians to report adverse events from the same system that contains patient electronic health records.