{"id":9682,"date":"2026-03-19T16:44:56","date_gmt":"2026-03-19T08:44:56","guid":{"rendered":"https:\/\/regask.com\/?p=9682"},"modified":"2026-03-19T16:46:03","modified_gmt":"2026-03-19T08:46:03","slug":"la-fda-de-ee-uu-presenta-aems-una-plataforma-unificada-para-la-notificacion-de-eventos-adversos-y-la-vigilancia-de-la-seguridad","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/u-s-fda-introduces-aems-a-unified-platform-for-adverse-event-reporting-and-safety-surveillance\/","title":{"rendered":"La FDA de EE. UU. presenta AEMS: una plataforma unificada para la prevenci\u00f3n de ataques\u2026"},"content":{"rendered":"<p><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">En <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">11 de marzo de 2026<\/span><\/span><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">, el\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA)<\/span><\/span><\/strong><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">\u00a0introdujo el<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">Sistema de Monitoreo de Eventos Adversos (AEMS)<\/span><\/span><\/strong><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\"><strong>,<\/strong> una plataforma centralizada dise\u00f1ada para optimizar la notificaci\u00f3n de eventos adversos en todos los \u00e1mbitos.\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">Categor\u00edas de productos regulados por la FDA<\/span><\/span><\/strong><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\"><strong>.<\/strong> El sistema afecta a las partes interesadas involucradas en\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\">farmacovigilancia, notificaci\u00f3n de seguridad y cumplimiento normativo<\/span><\/span><\/strong><span class=\"TextRun SCXW130125533 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW130125533 BCX0\"><strong>,<\/strong> que abarca sectores como productos m\u00e9dicos, vacunas, dispositivos m\u00e9dicos, tabaco, alimentos, cosm\u00e9ticos y medicamentos veterinarios.<\/span><\/span><span class=\"EOP SCXW130125533 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-2146471284\">\n\n\t<div id=\"col-808900268\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1679904692\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1679904692 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Detalles de la actualizaci\u00f3n<\/h2>\n\t<div id=\"gap-132178705\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-132178705 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">El reci\u00e9n lanzado\u00a0<\/span><b><span data-contrast=\"auto\">AEMS<\/span><\/b><span data-contrast=\"auto\">\u00a0reemplaza varios sistemas de informes heredados con un\u00a0<\/span><b><span data-contrast=\"auto\">plataforma \u00fanica y unificada<\/span><\/b><span data-contrast=\"auto\">, lo que permite protocolos de env\u00edo estandarizados y una mayor coherencia de los datos en todas las categor\u00edas de productos. Introduce\u00a0<\/span><b><span data-contrast=\"auto\">Flujos de trabajo avanzados para el procesamiento de casos<\/span><\/b><span data-contrast=\"auto\">\u00a0apoyado por\u00a0<\/span><b><span data-contrast=\"auto\">herramientas de redacci\u00f3n y digitalizaci\u00f3n basadas en inteligencia artificial<\/span><\/b><span data-contrast=\"auto\">, mejorando la eficiencia y la calidad de los informes presentados.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">El sistema tambi\u00e9n fortalece\u00a0<\/span><b><span data-contrast=\"auto\">capacidades de vigilancia entre productos<\/span><\/b><span data-contrast=\"auto\">\u00a0a trav\u00e9s de an\u00e1lisis mejorados, lo que permite a los reguladores y las partes interesadas identificar patrones y se\u00f1ales en diferentes tipos de productos. Adem\u00e1s de la notificaci\u00f3n de eventos adversos, AEMS brinda soporte\u00a0<\/span><b><span data-contrast=\"auto\">quejas de consumidores, informes de mala conducta regulatoria y denuncias de informantes<\/span><\/b><span data-contrast=\"auto\">, ampliando el alcance de la vigilancia de la seguridad.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Una caracter\u00edstica clave del sistema es la\u00a0<\/span><b><span data-contrast=\"auto\">Panel p\u00fablico de AEMS<\/span><\/b><span data-contrast=\"auto\">, que proporciona a las partes interesadas\u00a0<\/span><b><span data-contrast=\"auto\">Acceso con posibilidad de b\u00fasqueda a los eventos adversos notificados<\/span><\/b><span data-contrast=\"auto\">. Si bien esto promueve la transparencia y la usabilidad, la FDA enfatiza que los datos reportados\u00a0<\/span><b><span data-contrast=\"auto\">puede contener informaci\u00f3n duplicada o incompleta<\/span><\/b><span data-contrast=\"auto\">\u00a0y\u00a0<\/span><b><span data-contrast=\"auto\">No establece causalidad, tasas de incidencia ni perfiles definitivos de seguridad del producto.<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-808900268 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-610168994\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Por qu\u00e9 es importante<\/h2>\n\t<div id=\"gap-944452917\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-944452917 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">La implementaci\u00f3n de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">AEMS<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0mejora\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\"><strong>eficiencia regulatoria y datos<\/strong> <strong>integraci\u00f3n<\/strong><\/span><\/span><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0por\u00a0<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">consolidando<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0sistemas de informes dispares en un marco unificado. El uso de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">Herramientas con inteligencia artificial y flujos de trabajo estandarizados<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0admite una mejor calidad de datos y detecci\u00f3n de se\u00f1ales, mientras que el panel p\u00fablico se alinea con objetivos m\u00e1s amplios de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">transparencia y accesibilidad digital<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\"><strong>.<\/strong> En general, el sistema est\u00e1 dise\u00f1ado para fortalecer la supervisi\u00f3n de la seguridad del ciclo de vida, mientras que\u00a0<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">manteniendo<\/span><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0a\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">baja carga administrativa<\/span><\/span><\/strong><span class=\"TextRun SCXW91408954 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW91408954 BCX0\">\u00a0para las partes interesadas.<\/span><\/span><span class=\"EOP SCXW91408954 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-610168994 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-66029320\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Para qui\u00e9n es relevante<\/h2>\n\t<div id=\"gap-495734873\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-495734873 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para los profesionales en <strong>Asuntos regulatorios, farmacovigilancia, garant\u00eda de calidad, cumplimiento y equipos de TI,<\/strong> particularmente aquellos responsables de <strong>Notificaci\u00f3n de eventos adversos, gesti\u00f3n de datos de seguridad y presentaciones regulatorias.<\/strong> en todas las industrias reguladas por la FDA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-66029320 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1456403616\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Pr\u00f3ximos pasos<\/h2>\n\t<div id=\"gap-1830742651\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1830742651 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las organizaciones deber\u00edan\u00a0<\/span><b><span data-contrast=\"auto\">Revisar la funcionalidad de la plataforma AEMS.<\/span><\/b><span data-contrast=\"auto\">\u00a0y evaluar c\u00f3mo se alinean los flujos de trabajo de informes actuales con el nuevo sistema consolidado. Equipos responsables de\u00a0<\/span><b><span data-contrast=\"auto\">Notificaci\u00f3n de eventos adversos y gesti\u00f3n de quejas<\/span><\/b><span data-contrast=\"auto\">\u00a0Se les anima a familiarizarse con el\u00a0<\/span><b><span data-contrast=\"auto\">capacidades de consulta del panel p\u00fablico<\/span><\/b><span data-contrast=\"auto\">\u00a0y monitorear las actualizaciones en curso. Con el tiempo, las partes interesadas pueden considerar\u00a0<\/span><b><span data-contrast=\"auto\">Adaptaci\u00f3n de los procesos internos de gesti\u00f3n de datos y monitorizaci\u00f3n de se\u00f1ales.<\/span><\/b><span data-contrast=\"auto\">\u00a0para aprovechar un mejor acceso a informaci\u00f3n sobre seguridad aplicable a diferentes productos.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">A medida que los sistemas regulatorios contin\u00faan evolucionando hacia\u00a0<\/span><b><span data-contrast=\"auto\">plataformas centralizadas con capacidad de IA<\/span><\/b><span data-contrast=\"auto\">, soluciones como\u00a0<\/span><a href=\"http:\/\/regask.com\/es\/\"><b><span data-contrast=\"auto\">RegASK<\/span><\/b><\/a><span data-contrast=\"auto\">\u00a0puede ayudar a las organizaciones a anticiparse a estos cambios.\u00a0<a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a>\u00a0Es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA agentic que permite a organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Al combinar IA agentic avanzada con expertos en el sector,\u00a0<a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a>\u00a0Ofrece informaci\u00f3n predictiva y pr\u00e1ctica en tiempo real, as\u00ed como automatizaci\u00f3n integral, lo que agiliza los procesos de cumplimiento, mitiga los riesgos y acelera el acceso al mercado en m\u00e1s de 160 pa\u00edses.<strong><a href=\"http:\/\/regask.com\/es\/\"> M\u00e1s informaci\u00f3n<\/a> o <a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\">Reserve una demostraci\u00f3n ahora.<\/a><\/strong><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1456403616 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1520206842\">\n\n\t<div id=\"col-102773178\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>Preguntas frecuentes<\/h3>\n\t<div id=\"gap-2012818997\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2012818997 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW179543514 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW179543514 BCX0\">\u00bfQu\u00e9 es el Sistema de Monitoreo de Eventos Adversos (AEMS) de la FDA?<\/span><\/span><span class=\"EOP SCXW179543514 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-627764142\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-627764142 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El <strong>AEMS<\/strong> Es una plataforma centralizada lanzada por la FDA para gestionar la notificaci\u00f3n de eventos adversos en todas las categor\u00edas de productos reguladas por la FDA.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-102773178 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1241996835\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW250270229 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW250270229 BCX0\">\u00bfQu\u00e9 tipos de informes gestiona AEMS?<\/span><\/span><span class=\"EOP SCXW250270229 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1238746322\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1238746322 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>El sistema admite <strong>informes de eventos adversos, quejas de consumidores, informes de mala conducta regulatoria y denuncias de informantes. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1241996835 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-556370850\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW232842177 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232842177 BCX0\">\u00bfSe pueden utilizar los datos de AEMS para...?\u00a0<\/span><span class=\"NormalTextRun SCXW232842177 BCX0\">determinar<\/span><span class=\"NormalTextRun SCXW232842177 BCX0\">\u00a0\u00bfSeguridad del producto o causalidad?<\/span><\/span><span class=\"EOP SCXW232842177 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-44181791\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-44181791 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>No. La FDA afirma que los datos de AEMS <strong>no establece causalidad, tasas de incidencia ni perfiles de seguridad definitivos,<\/strong> y puede incluir informes incompletos o duplicados.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-556370850 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-761431245\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW252578696 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW252578696 BCX0\">\u00bfC\u00f3mo puedo?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW252578696 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW252578696 BCX0\">\u00a0\u00bfAyudar a las organizaciones a adaptarse a AEMS?<\/span><\/span><span class=\"EOP SCXW252578696 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-655582343\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-655582343 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW213849445 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><strong><a href=\"http:\/\/regask.com\/es\/\"><span class=\"NormalTextRun SpellingErrorV2Themed SCXW213849445 BCX0\">RegASK<\/span><\/a><\/strong><span class=\"NormalTextRun SCXW213849445 BCX0\">\u00a0ayuda a las organizaciones\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213849445 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213849445 BCX0\">monitor<\/span><span class=\"NormalTextRun SCXW213849445 BCX0\">\u00a0actualizaciones regulatorias, agilizar los flujos de trabajo de cumplimiento y\u00a0<\/span><span class=\"NormalTextRun SCXW213849445 BCX0\">aprovechar<\/span><span class=\"NormalTextRun SCXW213849445 BCX0\">\u00a0Informaci\u00f3n basada en inteligencia artificial<\/span><\/span><\/strong><span class=\"TextRun SCXW213849445 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213849445 BCX0\"><strong>,<\/strong> permitir una adaptaci\u00f3n m\u00e1s eficiente a sistemas como AEMS y mejorar las pr\u00e1cticas de gesti\u00f3n de datos de seguridad.<\/span><\/span><span class=\"EOP SCXW213849445 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-761431245 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 11 March 2026, the\u00a0U.S. Food and Drug Administration (FDA)\u00a0introduced theAdverse Event Monitoring System (AEMS), a centralized platform designed to streamline adverse event reporting across all\u00a0FDA-regulated product categories. The system impacts stakeholders involved in\u00a0pharmacovigilance, safety reporting, and regulatory compliance, covering sectors such as medical products, vaccines, medical devices, tobacco, food, cosmetics, and veterinary medicines.\u00a0<\/p>","protected":false},"author":43,"featured_media":9684,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,34],"tags":[],"class_list":["post-9682","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-food-beverage-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>U.S. FDA Introduces AEMS: Revolutionizing Reporting<\/title>\n<meta name=\"description\" content=\"Learn about the U.S. FDA&#039;s new AEMS 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