March 11 (Reuters) – The U.S. Food and Drug Administration said on Wednesday it has introduced a unified platform designed to streamline the analysis of reports on drug side effects.
* The new platform, called FDA Adverse Event MonitoringSystem (AEMS), would include adverse-event reports submitted tothe U.S. health regulator for drugs, biologics, vaccines,cosmetics and animal food on a single, streamlined dashboard. * AEMS will contain real-time adverse-event reports for allFDA-regulated products by the end of May. * The FDA will publish reports in real time, rather thanquarterly, potentially reducing the Freedom of Information Actrequests to the agency for unreleased adverse-event reports. * “The FDA’s previous adverse-event reporting systems wereoutdated and fragmented and made important data difficult toaccess,” said FDA Commissioner Marty Makary. * The agency said it has processed about 6 millionadverse-event reports per year across seven databases,collectively costing about $37 million a year. * The FDA expects to save about $120 million over the nextfive years through the AEMS platform. * The agency will also migrate historical adverse-event datato AEMS and decommission certain legacy systems, including FDAAdverse Event Reporting System and Vaccine Adverse EventReporting System.
(Reporting by Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar)
