{"id":9626,"date":"2026-03-11T15:04:43","date_gmt":"2026-03-11T07:04:43","guid":{"rendered":"https:\/\/regask.com\/?p=9626"},"modified":"2026-03-11T15:04:43","modified_gmt":"2026-03-11T07:04:43","slug":"la-fda-publica-una-guia-final-sobre-estudios-no-intervencionistas-que-utilizan-datos-del-mundo-real-para-la-seguridad-de-medicamentos-y-productos-biologicos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/","title":{"rendered":"La FDA emite una gu\u00eda final sobre estudios no intervencionistas\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">En\u00a0<\/span><b><span data-contrast=\"auto\">4 de marzo de 2026<\/span><\/b><span data-contrast=\"auto\">, el\u00a0<\/span><b><span data-contrast=\"auto\">Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA)<\/span><\/b><span data-contrast=\"auto\">\u00a0emitido\u00a0<\/span><b><span data-contrast=\"auto\">orientaci\u00f3n final<\/span><\/b><span data-contrast=\"auto\">\u00a0describiendo el\u00a0<\/span><b><span data-contrast=\"auto\">Principios generales para la planificaci\u00f3n, el dise\u00f1o, el an\u00e1lisis y la presentaci\u00f3n de informes de estudios no intervencionistas que utilizan datos del mundo real (RWD)<\/span><\/b><span data-contrast=\"auto\">\u00a0para evaluar la seguridad de los medicamentos. La gu\u00eda se aplica a\u00a0<\/span><b><span data-contrast=\"auto\">medicamentos, vacunas y productos biol\u00f3gicos<\/span><\/b><span data-contrast=\"auto\">\u00a0y establece expectativas regulatorias para\u00a0<\/span><b><span data-contrast=\"auto\">estudios de seguridad posteriores a la comercializaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0realizado por patrocinadores farmac\u00e9uticos y biol\u00f3gicos.<\/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 documento estandariza c\u00f3mo deben realizarse los estudios no intervencionistas cuando se utilizan\u00a0<\/span><b><span data-contrast=\"auto\">fuentes de datos del mundo real, como registros m\u00e9dicos electr\u00f3nicos y reclamaciones de seguros<\/span><\/b><span data-contrast=\"auto\">, que aporta claridad sobre el dise\u00f1o del estudio, la metodolog\u00eda y las pr\u00e1cticas de presentaci\u00f3n de informes. Reemplaza el borrador de gu\u00eda anterior y\u00a0<\/span><b><span data-contrast=\"auto\">Retira la gu\u00eda de la FDA de mayo de 2013 sobre estudios de seguridad farmacoepidemiol\u00f3gica que utilizan conjuntos de datos electr\u00f3nicos de atenci\u00f3n m\u00e9dica.<\/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<div class=\"row\"  id=\"row-1745919475\">\n\n\t<div id=\"col-1381534754\" 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-1659949065\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1659949065 {\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-1602202571\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1602202571 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">La gu\u00eda final define\u00a0<\/span><b><span data-contrast=\"auto\">estudios no intervencionistas<\/span><\/b><span data-contrast=\"auto\">\u00a0como enfoques de investigaci\u00f3n que observan resultados sin asignar tratamientos o intervenciones espec\u00edficos. Estos estudios se basan en datos reales recopilados durante la atenci\u00f3n m\u00e9dica rutinaria.<\/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\">La FDA recomienda que los patrocinadores comiencen por\u00a0<\/span><b><span data-contrast=\"auto\">formular claramente las preguntas de investigaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0e identificar fuentes de datos reales apropiadas que puedan respaldar evaluaciones de seguridad confiables. La gu\u00eda tambi\u00e9n enfatiza la necesidad de\u00a0<\/span><b><span data-contrast=\"auto\">definir con precisi\u00f3n las variables de estudio y los puntos finales<\/span><\/b><span data-contrast=\"auto\">, garantizando que los conjuntos de datos y los enfoques anal\u00edticos sean adecuados para la evaluaci\u00f3n de seguridad prevista.<\/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\">Adem\u00e1s, el documento destaca la importancia de\u00a0<\/span><b><span data-contrast=\"auto\">Abordar el sesgo y los factores de confusi\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0Durante el dise\u00f1o y an\u00e1lisis del estudio, se espera que los patrocinadores incorporen m\u00e9todos para identificar, evaluar y mitigar posibles fuentes de sesgo que puedan afectar las conclusiones sobre 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\">La FDA describe adem\u00e1s las expectativas para\u00a0<\/span><b><span data-contrast=\"auto\">Documentaci\u00f3n de estudios transparente e informes completos<\/span><\/b><span data-contrast=\"auto\">, incluidas descripciones detalladas de las metodolog\u00edas, fuentes de datos y enfoques anal\u00edticos utilizados en el estudio.<\/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-1381534754 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1317954384\" 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>Fecha de entrada en vigor<\/h2>\n\t<div id=\"gap-1932758143\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1932758143 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">El\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">Gu\u00eda final de la FDA sobre estudios no intervencionistas que utilizan datos del mundo real<\/span><\/span><\/strong><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">\u00a0convertirse\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">eficaz en <strong>4 de marzo de 2026<\/strong><\/span><\/span><strong><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">.<\/span><\/span><span class=\"EOP SCXW15748117 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1317954384 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1675911437\" 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-67260919\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-67260919 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">Esta actualizaci\u00f3n proporciona<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">Claridad regulatoria para el uso de datos del mundo real en la vigilancia de seguridad posterior a la comercializaci\u00f3n<\/span><\/span><\/strong><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\"><strong>.<\/strong> Al estandarizar el dise\u00f1o de estudios, la gesti\u00f3n de sesgos y las pr\u00e1cticas de informes, la gu\u00eda respalda m\u00e1s\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">evaluaciones de seguridad consistentes, confiables y transparentes<\/span><\/span><\/strong><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">\u00a0al tiempo que permite un uso eficiente de las fuentes de datos sanitarios existentes.<\/span><\/span><span class=\"EOP SCXW234709501 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-1675911437 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1091363778\" 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-1068417235\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1068417235 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">La orientaci\u00f3n es relevante para los equipos involucrados en\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">vigilancia poscomercializaci\u00f3n y evaluaci\u00f3n de seguridad<\/span><\/span><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">, <\/span><\/span><\/strong><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">incluido<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">Asuntos regulatorios, garant\u00eda de calidad, seguridad del paciente, legal y cumplimiento, comercial o de marketing y funciones de I+D<\/span><\/span><\/strong><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">\u00a0dentro de las organizaciones farmac\u00e9uticas y biol\u00f3gicas.<\/span><\/span><span class=\"EOP SCXW75709743 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-1091363778 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-593947550\" 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-1773332944\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1773332944 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Organizaciones que realizan\u00a0<\/span><b><span data-contrast=\"auto\">estudios de seguridad no intervencionistas que utilizan datos del mundo real<\/span><\/b><span data-contrast=\"auto\">\u00a0Deben revisar los protocolos y metodolog\u00edas de estudio actuales para garantizar su conformidad con las expectativas actualizadas de la FDA. Las partes interesadas tambi\u00e9n deben evaluar las pr\u00e1cticas de documentaci\u00f3n y los procesos de presentaci\u00f3n de informes en los departamentos pertinentes para confirmar que los dise\u00f1os de los estudios, los m\u00e9todos de selecci\u00f3n de datos y los enfoques anal\u00edticos cumplen con los nuevos est\u00e1ndares.<\/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 las agencias reguladoras formalizan cada vez m\u00e1s las expectativas en torno a los datos del mundo real y el monitoreo de seguridad posterior a la comercializaci\u00f3n, las organizaciones pueden beneficiarse de herramientas que ayuden a rastrear la evoluci\u00f3n de las pautas regulatorias y operacionalizar el cumplimiento en los mercados globales.<\/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 href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a>\u00a0es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujo de trabajo con inteligencia artificial (IA) que permite a las organizaciones globales en sectores altamente regulados, incluidos productos de consumo y ciencias biol\u00f3gicas, navegar de manera proactiva en panoramas regulatorios complejos.<strong> Al combinar la IA avanzada de Agentic con expertos en el sector,\u00a0<a href=\"http:\/\/regask.com\/es\/\">RegASK<\/a><\/strong> Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, agilizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de 160 pa\u00edses. <strong><a href=\"http:\/\/regask.com\/es\/\">M\u00e1s informaci\u00f3n<\/a> <\/strong>o<a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong> Reserve una demostraci\u00f3n ahora.<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-593947550 > .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-1814319357\">\n\n\t<div id=\"col-1233741181\" 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-1992613143\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1992613143 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW22959475 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW22959475 BCX0\">\u00bfCu\u00e1l es la gu\u00eda de la FDA para 2026 sobre estudios no intervencionistas que utilizan datos del mundo real?<\/span><\/span><span class=\"EOP SCXW22959475 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-1358188894\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1358188894 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW182041197 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182041197 BCX0\">La gu\u00eda describe\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW182041197 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182041197 BCX0\">Principios generales para la planificaci\u00f3n, el dise\u00f1o, el an\u00e1lisis y la presentaci\u00f3n de informes de estudios no intervencionistas que utilizan datos del mundo real.<\/span><\/span><\/strong><span class=\"TextRun SCXW182041197 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182041197 BCX0\">\u00a0Evaluar la seguridad de medicamentos, vacunas y productos biol\u00f3gicos en entornos posteriores a su comercializaci\u00f3n.<\/span><\/span><span class=\"EOP SCXW182041197 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-1233741181 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-561269268\" 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 SCXW169711913 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW169711913 BCX0\">\u00bfQu\u00e9 tipos de datos se consideran datos del mundo real en esta gu\u00eda?<\/span><\/span><span class=\"EOP SCXW169711913 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-340689939\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-340689939 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW97422678 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97422678 BCX0\">La FDA\u00a0<\/span><span class=\"NormalTextRun SCXW97422678 BCX0\">identifica<\/span><span class=\"NormalTextRun SCXW97422678 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW97422678 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97422678 BCX0\">fuentes de datos como registros m\u00e9dicos electr\u00f3nicos y reclamaciones de seguros<\/span><\/span><\/strong><span class=\"TextRun SCXW97422678 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97422678 BCX0\">\u00a0como ejemplos de datos del mundo real que pueden utilizarse en estudios de seguridad no intervencionistas.<\/span><\/span><span class=\"EOP SCXW97422678 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-561269268 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1195522975\" 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 SCXW258517632 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW258517632 BCX0\">\u00bfEsta gu\u00eda reemplaza?\u00a0<\/span><span class=\"NormalTextRun SCXW258517632 BCX0\">anterior<\/span><span class=\"NormalTextRun SCXW258517632 BCX0\">\u00a0\u00bfRecomendaciones de la FDA?<\/span><\/span><span class=\"EOP SCXW258517632 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-1877591770\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1877591770 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW185775808 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185775808 BCX0\">S\u00ed. La orientaci\u00f3n final<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW185775808 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185775808 BCX0\">Retira la gu\u00eda de la FDA de mayo de 2013 sobre estudios de seguridad farmacoepidemiol\u00f3gica que utilizan conjuntos de datos electr\u00f3nicos de atenci\u00f3n m\u00e9dica.<\/span><\/span><\/strong><span class=\"TextRun SCXW185775808 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185775808 BCX0\">\u00a0y sustituye los borradores de recomendaciones anteriores.<\/span><\/span><span class=\"EOP SCXW185775808 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-1195522975 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1316797496\" 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>\u00bfC\u00f3mo puede RegASK ayudar a las empresas a monitorear las actualizaciones regulatorias relacionadas con las f\u00f3rmulas infantiles?<\/h4>\n\t<div id=\"gap-1724654476\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1724654476 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW177493038 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW177493038 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW177493038 BCX0\">\u00a0ayuda a las organizaciones\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW177493038 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW177493038 BCX0\">Realizar un seguimiento de la evoluci\u00f3n de las directrices regulatorias, interpretar los requisitos de cumplimiento y optimizar los flujos de trabajo regulatorios<\/span><\/span><\/strong><span class=\"TextRun SCXW177493038 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW177493038 BCX0\"><strong>,<\/strong> permitiendo que los equipos regulatorios, de seguridad y de cumplimiento respondan de manera m\u00e1s eficiente a actualizaciones como la nueva gu\u00eda de la FDA sobre estudios de datos del mundo real.<\/span><\/span><span class=\"EOP SCXW177493038 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-1316797496 > .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\u00a0March 4, 2026, the\u00a0U.S. Food and Drug Administration (FDA)\u00a0issued\u00a0final guidance\u00a0outlining the\u00a0general principles for planning, designing, analyzing, and reporting non-interventional studies that use real-world data (RWD)\u00a0to assess the safety of medicines. The guidance applies to\u00a0drugs, vaccines, and biological products\u00a0and\u00a0establishes\u00a0regulatory expectations for\u00a0postmarketing safety studies\u00a0conducted by pharmaceutical and biologics sponsors.\u00a0 The document standardizes how non-interventional studies should be&#8230;<\/p>","protected":false},"author":43,"featured_media":9627,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9626","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Issues Final Guidance on Non-Interventional Studies<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s final guidance on non-interventional studies using real-world data for drug and biologic safety assessments.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/la-fda-publica-una-guia-final-sobre-estudios-no-intervencionistas-que-utilizan-datos-del-mundo-real-para-la-seguridad-de-medicamentos-y-productos-biologicos\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Final Guidance on Non-Interventional Studies Using Real-World Data for Drug and Biologic Safety\" \/>\n<meta property=\"og:description\" content=\"Explore the FDA&#039;s final guidance on non-interventional studies using real-world data for drug and biologic safety assessments.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/la-fda-publica-una-guia-final-sobre-estudios-no-intervencionistas-que-utilizan-datos-del-mundo-real-para-la-seguridad-de-medicamentos-y-productos-biologicos\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-11T07:04:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Reva Ananda\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Reva Ananda\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"FDA Issues Final Guidance on Non-Interventional Studies&hellip;\",\"datePublished\":\"2026-03-11T07:04:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/\"},\"wordCount\":853,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png\",\"articleSection\":[\"United States\",\"Regulatory News\",\"Pharma and Biotech\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/\",\"name\":\"FDA Issues Final Guidance on Non-Interventional Studies\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png\",\"datePublished\":\"2026-03-11T07:04:43+00:00\",\"description\":\"Explore the FDA's final guidance on non-interventional studies using real-world data for drug and biologic safety assessments.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png\",\"width\":800,\"height\":600,\"caption\":\"Fda Issues Final Guidance Non Interventional Studies Real World Data Drug Biologic Safety\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\",\"name\":\"Reva Ananda\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"La FDA publica una gu\u00eda final sobre estudios no intervencionistas","description":"Explore la gu\u00eda final de la FDA sobre estudios no intervencionistas que utilizan datos del mundo real para evaluaciones de seguridad de medicamentos y productos biol\u00f3gicos.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/es\/la-fda-publica-una-guia-final-sobre-estudios-no-intervencionistas-que-utilizan-datos-del-mundo-real-para-la-seguridad-de-medicamentos-y-productos-biologicos\/","og_locale":"es_ES","og_type":"article","og_title":"FDA Issues Final Guidance on Non-Interventional Studies Using Real-World Data for Drug and Biologic Safety","og_description":"Explore the FDA's final guidance on non-interventional studies using real-world data for drug and biologic safety assessments.","og_url":"https:\/\/regask.com\/es\/la-fda-publica-una-guia-final-sobre-estudios-no-intervencionistas-que-utilizan-datos-del-mundo-real-para-la-seguridad-de-medicamentos-y-productos-biologicos\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-03-11T07:04:43+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png","type":"image\/png"}],"author":"Reva Ananda","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Reva Ananda","Est. reading time":"4 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/#article","isPartOf":{"@id":"https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/"},"author":{"name":"Reva Ananda","@id":"https:\/\/regask.com\/#\/schema\/person\/4023a3aab44f61a84d06ca8abfcbe926"},"headline":"FDA Issues Final Guidance on Non-Interventional Studies&hellip;","datePublished":"2026-03-11T07:04:43+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/"},"wordCount":853,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png","articleSection":["United States","Regulatory News","Pharma and Biotech"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/","url":"https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/","name":"La FDA publica una gu\u00eda final sobre estudios no intervencionistas","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png","datePublished":"2026-03-11T07:04:43+00:00","description":"Explore la gu\u00eda final de la FDA sobre estudios no intervencionistas que utilizan datos del mundo real para evaluaciones de seguridad de medicamentos y productos biol\u00f3gicos.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png","width":800,"height":600,"caption":"Fda Issues Final Guidance Non Interventional Studies Real World Data Drug Biologic Safety"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"El sistema operativo de IA regulatoria para equipos de alto rendimiento","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/4023a3aab44f61a84d06ca8abfcbe926","name":"Reva Ananda"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9626","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/users\/43"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/comments?post=9626"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9626\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/9627"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=9626"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=9626"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=9626"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}