{"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-2096753310\">\n\n\t<div id=\"col-1915147531\" 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-299463705\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-299463705 {\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-1221287192\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1221287192 {\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-1915147531 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2039363538\" 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-1866330819\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1866330819 {\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-2039363538 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1598282977\" 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-1887130769\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1887130769 {\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-1598282977 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-958860904\" 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-1946770078\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1946770078 {\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-958860904 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-645937600\" 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-1985673317\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1985673317 {\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-645937600 > .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-2128268484\">\n\n\t<div id=\"col-2125144839\" 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-1870353141\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1870353141 {\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-1715062337\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1715062337 {\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-2125144839 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-424767989\" 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-471246150\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-471246150 {\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-424767989 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-995303877\" 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-863261196\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-863261196 {\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-995303877 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-27373617\" 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-709009392\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-709009392 {\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-27373617 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El 4 de marzo de 2026, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) public\u00f3 una gu\u00eda definitiva que describe los 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 (DMR) para evaluar la seguridad de los medicamentos. La gu\u00eda se aplica a medicamentos, vacunas y productos biol\u00f3gicos, y establece las expectativas regulatorias para los estudios de seguridad posteriores a la comercializaci\u00f3n realizados por los patrocinadores de productos farmac\u00e9uticos y biol\u00f3gicos. El documento estandariza la forma en que deben realizarse los estudios no intervencionistas\u2026<\/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 v28.7 (Yoast SEO v28.7) - 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\" 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