{"id":9620,"date":"2026-03-11T14:41:45","date_gmt":"2026-03-11T06:41:45","guid":{"rendered":"https:\/\/regask.com\/?p=9620"},"modified":"2026-03-11T15:50:07","modified_gmt":"2026-03-11T07:50:07","slug":"la-fda-publica-un-borrador-de-guia-sobre-la-exclusividad-de-investigacion-clinica-de-tres-anos-para-acuerdos-de-donacion-de-medicamentos-nda-y-suplementos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/","title":{"rendered":"La FDA publica un borrador de gu\u00eda sobre investigaci\u00f3n cl\u00ednica a tres a\u00f1os\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\">\u00a0public\u00f3 una\u00a0<\/span><b><span data-contrast=\"auto\">proyecto de documento de orientaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0direccionamiento\u00a0<\/span><b><span data-contrast=\"auto\">Exclusividad de investigaci\u00f3n cl\u00ednica durante tres a\u00f1os<\/span><\/b><span data-contrast=\"auto\">\u00a0para productos farmac\u00e9uticos. La gu\u00eda aclara las expectativas regulatorias para los solicitantes que buscan exclusividad para\u00a0<\/span><b><span data-contrast=\"auto\">solicitudes de nuevos f\u00e1rmacos (NDA)<\/span><\/b><span data-contrast=\"auto\">\u00a0y\u00a0<\/span><b><span data-contrast=\"auto\">Suplementos NDA<\/span><\/b><span data-contrast=\"auto\">, especialmente cuando nuevas investigaciones cl\u00ednicas respaldan estas presentaciones.<\/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 proyecto de gu\u00eda tiene como objetivo ayudar a los solicitantes a comprender la\u00a0<\/span><b><span data-contrast=\"auto\">criterios de elegibilidad legales y reglamentarios<\/span><\/b><span data-contrast=\"auto\">\u00a0requerido para obtener\u00a0<\/span><b><span data-contrast=\"auto\">Exclusividad de 3 a\u00f1os<\/span><\/b><span data-contrast=\"auto\">. Tambi\u00e9n proporciona recomendaciones sobre la\u00a0<\/span><b><span data-contrast=\"auto\">Contenido y formato de las solicitudes de exclusividad<\/span><\/b><span data-contrast=\"auto\">, presentado de forma estructurada\u00a0<\/span><b><span data-contrast=\"auto\">formato de preguntas y respuestas<\/span><\/b><span data-contrast=\"auto\">. El documento est\u00e1 actualmente abierto a comentarios p\u00fablicos hasta\u00a0<\/span><b><span data-contrast=\"auto\">4 de mayo de 2026<\/span><\/b><span data-contrast=\"auto\">, despu\u00e9s de lo cual la FDA revisar\u00e1 los comentarios de las partes interesadas antes de finalizar la gu\u00eda.<\/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-1013141794\">\n\n\t<div id=\"col-1403708075\" 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-912126746\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-912126746 {\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-913048676\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-913048676 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">El proyecto de orientaci\u00f3n describe\u00a0<\/span><b><span data-contrast=\"auto\">est\u00e1ndares de documentaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0que los solicitantes deben seguir al solicitar\u00a0<\/span><b><span data-contrast=\"auto\">Investigaci\u00f3n cl\u00ednica de tres a\u00f1os sobre exclusividad<\/span><\/b><span data-contrast=\"auto\">. Proporciona recomendaciones detalladas sobre c\u00f3mo presentar la informaci\u00f3n necesaria para respaldar una solicitud de exclusividad como parte de una presentaci\u00f3n de NDA o de un suplemento de NDA.<\/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 gu\u00eda se aplica a ambos\u00a0<\/span><b><span data-contrast=\"auto\">acuerdos de confidencialidad originales<\/span><\/b><span data-contrast=\"auto\">\u00a0y\u00a0<\/span><b><span data-contrast=\"auto\">Suplementos NDA<\/span><\/b><span data-contrast=\"auto\">\u00a0que dependen de\u00a0<\/span><b><span data-contrast=\"auto\">nuevos estudios cl\u00ednicos<\/span><\/b><span data-contrast=\"auto\">. Al aclarar las expectativas sobre el formato y la informaci\u00f3n de respaldo requerida, la FDA busca mejorar la coherencia en la forma en que los solicitantes presentan sus solicitudes de exclusividad.<\/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, la agencia se\u00f1ala que la orientaci\u00f3n seguir\u00e1 evolucionando.\u00a0<\/span><b><span data-contrast=\"auto\">Las futuras actualizaciones pueden incluir preguntas y respuestas adicionales.<\/span><\/b><span data-contrast=\"auto\">\u00a0a medida que surgen nuevos escenarios regulatorios y se incorpora la retroalimentaci\u00f3n de las partes interesadas.<\/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-1403708075 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-785137143\" 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 l\u00edmite para comentarios<\/h2>\n\t<div id=\"gap-451430203\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-451430203 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">Las partes interesadas pueden\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">entregar<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u00a0comentarios sobre el\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">Borrador de orientaci\u00f3n de la FDA\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">acerca de<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\"> Exclusividad de investigaci\u00f3n cl\u00ednica durante tres a\u00f1os\u00a0<\/span><\/span><\/strong><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">hasta <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">4 de mayo de 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\"><strong>.<\/strong> Los comentarios pueden ser\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">enviado<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u00a0a trav\u00e9s de la FDA\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">canales de presentaci\u00f3n en l\u00ednea o escritos<\/span><\/span><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">.<\/span><\/span><span class=\"EOP SCXW57646166 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-785137143 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1839653795\" 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-1622064412\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1622064412 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">El proyecto de orientaci\u00f3n proporciona mayor\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">claridad regulatoria<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u00a0sobre los requisitos de elegibilidad y documentaci\u00f3n para\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">exclusividad de datos durante tres a\u00f1os<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u00a0asociados con las aprobaciones de medicamentos en Estados Unidos. Unas expectativas m\u00e1s claras pueden ayudar a agilizar la preparaci\u00f3n y el apoyo de las solicitudes.<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">consistencia regulatoria<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\"><strong>,<\/strong> y reducir la incertidumbre para los patrocinadores que preparan NDA o suplementos respaldados por nuevas investigaciones cl\u00ednicas.<\/span><\/span><span class=\"EOP SCXW213098303 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-1839653795 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1858871324\" 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-1102400895\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1102400895 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">Esta actualizaci\u00f3n es particularmente relevante para\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">fabricantes farmac\u00e9uticos, patrocinadores cl\u00ednicos, equipos de asuntos regulatorios y profesionales de cumplimiento<\/span><\/span><\/strong><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">\u00a0responsable de preparar\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\"><strong>Presentaciones de NDA o suplementos respaldados por estudios cl\u00ednicos<\/strong><\/span><\/span><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\"><strong>.<\/strong> Las organizaciones involucradas en el desarrollo de medicamentos y procesos de autorizaci\u00f3n de comercializaci\u00f3n en los EE. UU. deben revisar el borrador de la gu\u00eda para comprender sus implicaciones para las solicitudes de exclusividad.<\/span><\/span><span class=\"EOP SCXW4282818 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-1858871324 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1549404565\" 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-376649381\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-376649381 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Los equipos reguladores deber\u00edan revisar la\u00a0<\/span><b><span data-contrast=\"auto\">Proyecto de gu\u00eda de la FDA sobre la exclusividad de la investigaci\u00f3n cl\u00ednica durante tres a\u00f1os<\/span><\/b><span data-contrast=\"auto\">\u00a0y evaluar c\u00f3mo puede afectar\u00a0<\/span><b><span data-contrast=\"auto\">Presentaciones de NDA y suplementos de NDA actuales o planificadas<\/span><\/b><span data-contrast=\"auto\">. Las partes interesadas tambi\u00e9n pueden considerar preparar comentarios, sugerencias o preguntas aclaratorias para enviarlas antes de la\u00a0<\/span><b><span data-contrast=\"auto\">Fecha l\u00edmite para comentarios: 4 de mayo de 2026<\/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<p><span data-contrast=\"auto\">Las organizaciones que gestionan m\u00faltiples presentaciones regulatorias en diferentes mercados tambi\u00e9n pueden beneficiarse de herramientas de inteligencia regulatoria centralizadas que ayudan a rastrear la evoluci\u00f3n de las pautas y las expectativas de presentaci\u00f3n.<\/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 un l\u00edder\u00a0<\/span><b><span data-contrast=\"auto\">Plataforma de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con inteligencia artificial de Agentic<\/span><\/b><span data-contrast=\"auto\">\u00a0que permite a las organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, navegar proactivamente en entornos regulatorios complejos. Al combinar tecnolog\u00eda avanzada\u00a0<\/span><b><span data-contrast=\"auto\">IA agente<\/span><\/b><span data-contrast=\"auto\">\u00a0con expertos en el sector,\u00a0<a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a>\u00a0Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, optimizando los procesos de cumplimiento, mitigando riesgos y acelerando el acceso al mercado en m\u00e1s de\u00a0<\/span><b><span data-contrast=\"auto\">160 pa\u00edses<\/span><\/b><span data-contrast=\"auto\">. <a href=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n <\/strong><\/a>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-1549404565 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1086695840\" 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-904096389\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-904096389 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las partes interesadas deben revisar la <strong>Recursos web actualizados de la FDA sobre f\u00f3rmulas infantiles<\/strong> y el nuevo <strong>lista de mercado publicada<\/strong> para garantizar que los registros internos y la informaci\u00f3n p\u00fablica del producto est\u00e9n alineados.<\/p>\n<p>Los equipos regulatorios, de calidad y comerciales deben verificar que <strong>Los listados de productos y la informaci\u00f3n de la empresa se reflejan con precisi\u00f3n.<\/strong> en la base de datos p\u00fablica. Las organizaciones tambi\u00e9n pueden considerar monitorear futuras iniciativas de transparencia bajo <strong>Operaci\u00f3n Velocidad de Cig\u00fce\u00f1a<\/strong> mantenerse informado sobre posibles novedades pol\u00edticas o acciones regulatorias.<\/p>\n<p>A medida que las iniciativas de transparencia regulatoria contin\u00faan evolucionando, mantener la visibilidad de las actualizaciones regulatorias globales se vuelve cada vez m\u00e1s importante. <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> Ayuda a las organizaciones a monitorear los desarrollos regulatorios y gestionar el cumplimiento de los flujos de trabajo en m\u00faltiples jurisdicciones.<\/p>\n<p><a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> es 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, <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. <a href=\"http:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n <\/strong><\/a>o<strong><a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"> Reserve una demostraci\u00f3n ahora.<\/a>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1086695840 > .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-1960820616\">\n\n\t<div id=\"col-725303157\" 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-1907818356\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1907818356 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW99703309 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW99703309 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfCu\u00e1l es el borrador de gu\u00eda de la FDA sobre la exclusividad de la investigaci\u00f3n cl\u00ednica durante tres a\u00f1os?<\/span><\/span><span class=\"EOP SCXW99703309 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1884348007\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1884348007 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">El\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">El borrador de la gu\u00eda de la FDA se public\u00f3 el 4 de marzo,\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW263241192 BCX0\">2026<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>\u00a0<\/strong>Proporciona recomendaciones para los solicitantes que buscan<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">Exclusividad de investigaci\u00f3n cl\u00ednica durante tres a\u00f1os<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0para\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">solicitudes de nuevos f\u00e1rmacos (NDA)<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">o<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">Suplementos NDA<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>.<\/strong>\u00a0<\/span><span class=\"NormalTextRun SCXW263241192 BCX0\">Explica el\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">criterios de elegibilidad<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>\u00a0<\/strong>y describe el\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">contenido y formato<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0esperado para solicitudes de exclusividad.<\/span><\/span><span class=\"EOP SCXW263241192 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-725303157 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-36671096\" 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 SCXW114531365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW114531365 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfQui\u00e9n puede solicitar exclusividad en investigaci\u00f3n cl\u00ednica por tres a\u00f1os?<\/span><\/span><span class=\"EOP SCXW114531365 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1656077062\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1656077062 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">Solicitantes\u00a0<\/span><span class=\"NormalTextRun SCXW124616724 BCX0\">sumisi\u00f3n<\/span><span class=\"NormalTextRun SCXW124616724 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">NDA originales o suplementos de NDA respaldados por nuevas investigaciones cl\u00ednicas<\/span><\/span><\/strong><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">\u00a0puede solicitar\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">exclusividad de tres a\u00f1os<\/span><\/span><\/strong><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\"><strong>,<\/strong> siempre que cumplan con los requisitos de elegibilidad legales y reglamentarios descritos por la FDA.<\/span><\/span><span class=\"EOP SCXW124616724 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-36671096 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-642214806\" 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 SCXW110399116 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfCu\u00e1ndo es la fecha l\u00edmite para\u00a0<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">entregar<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0\u00bfComentarios sobre el borrador de gu\u00eda de la FDA?<\/span><\/span><span class=\"EOP SCXW110399116 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1785976185\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1785976185 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">Las partes interesadas pueden\u00a0<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">entregar<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">\u00a0retroalimentaci\u00f3n sobre el\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">proyecto de orientaci\u00f3n<\/span><\/span><\/strong><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">hasta<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">4 de mayo de 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\"><strong>,<\/strong> utilizando la FDA\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">canales de presentaci\u00f3n en l\u00ednea o escritos<\/span><\/span><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">.<\/span><\/span><span class=\"EOP SCXW109329519 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-642214806 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-767377457\" 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 gestionar los requisitos de etiquetado de OGM?<\/h4>\n\t<div id=\"gap-1082343666\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1082343666 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW19024172 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0proporciona\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">Inteligencia regulatoria impulsada por IA y automatizaci\u00f3n del flujo de trabajo<\/span><\/span><\/strong><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0que permite a las organizaciones\u00a0<\/span><span class=\"NormalTextRun SCXW19024172 BCX0\">monitor<\/span><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">Actualizaciones de las directrices de la FDA, cambios regulatorios y requisitos de presentaci\u00f3n<\/span><\/span><\/strong><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0en los mercados globales. Esto ayuda a los equipos regulatorios y de cumplimiento a mantenerse informados, evaluar el impacto regulatorio y agilizar la preparaci\u00f3n de las presentaciones.<\/span><\/span><span class=\"EOP SCXW19024172 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-767377457 > .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)\u00a0published a\u00a0draft guidance document\u00a0addressing\u00a0three-year clinical investigation exclusivity\u00a0for drug products. The guidance clarifies regulatory expectations for applicants seeking exclusivity for\u00a0new drug applications (NDAs)\u00a0and\u00a0NDA supplements, particularly when new clinical investigations support these submissions.\u00a0 The draft guidance is intended to help applicants understand the\u00a0statutory and regulatory eligibility criteria\u00a0required\u00a0to obtain\u00a03-year exclusivity&#8230;.<\/p>","protected":false},"author":43,"featured_media":9621,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,39],"tags":[],"class_list":["post-9620","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Issues Draft Guidance on Three-Year Exclusivity<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. Learn more today.\" \/>\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-un-borrador-de-guia-sobre-la-exclusividad-de-investigacion-clinica-de-tres-anos-para-acuerdos-de-donacion-de-medicamentos-nda-y-suplementos\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Draft Guidance on Three-Year Clinical Investigation Exclusivity for NDAs and Supplements\" \/>\n<meta property=\"og:description\" content=\"Explore the FDA&#039;s draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. 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