{"id":9589,"date":"2026-03-03T22:23:32","date_gmt":"2026-03-03T14:23:32","guid":{"rendered":"https:\/\/regask.com\/?p=9589"},"modified":"2026-03-03T22:23:32","modified_gmt":"2026-03-03T14:23:32","slug":"la-fda-publica-un-borrador-de-directrices-especificas-para-productos-con-el-fin-de-respaldar-el-desarrollo-de-medicamentos-genericos-y-las-aprobaciones-de-la-anda","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-issues-draft-product-specific-guidances-to-support-generic-drug-development-and-anda-approvals\/","title":{"rendered":"La FDA publica un borrador de directrices espec\u00edficas para cada producto en apoyo..."},"content":{"rendered":"<p>En <strong>26 de febrero de 2026, <\/strong>el<strong> La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) public\u00f3 un lote de borradores de gu\u00edas espec\u00edficas del producto (PSG)<\/strong> destinado a apoyar el desarrollo de medicamentos gen\u00e9ricos y agilizar su aplicaci\u00f3n <strong>Solicitud Abreviada de Nuevo Medicamento (ANDA)<\/strong> Aprobaciones para productos farmac\u00e9uticos. La actualizaci\u00f3n afecta a las empresas y equipos involucrados en el desarrollo, la presentaci\u00f3n o la revisi\u00f3n de ANDA, en particular para ambos <strong>productos gen\u00e9ricos complejos y no complejos. <\/strong><\/p>\n<div class=\"row\"  id=\"row-329413677\">\n\n\t<div id=\"col-1090950130\" 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-1063853203\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1063853203 {\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-1570004974\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1570004974 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La FDA public\u00f3 borradores de PSG nuevos y revisados que describen las expectativas regulatorias para demostrar <strong>equivalencia terap\u00e9utica<\/strong> para hacer referencia a los medicamentos enumerados. Las gu\u00edas cubren 98 productos, incluidos aquellos con <strong>No hay gen\u00e9ricos aprobados actualmente,<\/strong> e introducir nuevas directrices para <strong>tratamientos para el trastorno por consumo de opioides <\/strong>y<strong> Semaglutida oral para la reducci\u00f3n del riesgo cardiovascular.\u00a0<\/strong><\/p>\n<p>Se revisaron varios PSG existentes, con actualizaciones que afectan <strong>formulaciones de liberaci\u00f3n modificada y sistemas transd\u00e9rmicos y t\u00f3picos,<\/strong> lo que resulta en cambios en las expectativas de estudio, tales como<strong> estudios sobre la reducci\u00f3n de la dosis de alcohol <\/strong>y<strong> pruebas de sensibilizaci\u00f3n.<\/strong> Adem\u00e1s, la FDA actualiz\u00f3 su lista en l\u00ednea para incluir <strong>pr\u00f3ximos PSG en desarrollo,<\/strong> junto con las fechas de publicaci\u00f3n previstas para respaldar la planificaci\u00f3n del desarrollo.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1090950130 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-373857825\" 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-1492814473\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1492814473 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Estos proyectos del PSG aportan mayor <strong>claridad regulatoria<\/strong> sobre el dise\u00f1o de estudios y los requisitos de datos para el desarrollo de medicamentos gen\u00e9ricos, apoyando <strong>Alineaci\u00f3n digital y eficiencia de la planificaci\u00f3n<\/strong> para los programas ANDA. Al aclarar las expectativas en productos complejos y no complejos, la actualizaci\u00f3n busca mejorar la previsibilidad y, al mismo tiempo, mantener... <strong>impacto neutral y carga regulatoria adicional m\u00ednima<\/strong> para las partes interesadas de la industria.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-373857825 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1893595655\" 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-289820297\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-289820297 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Esta actualizaci\u00f3n es relevante para <strong>Asuntos Regulatorios, Garant\u00eda de Calidad, I+D, <\/strong>y<strong> Equipos legales<\/strong> involucrados en el desarrollo de medicamentos gen\u00e9ricos y presentaciones ANDA, particularmente aquellos que trabajan en formulaciones complejas o productos con requisitos de estudio cambiantes.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1893595655 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1237118671\" 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-820682950\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-820682950 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Las empresas deber\u00edan <strong>evaluar las presentaciones ANDA actuales y planificadas<\/strong> Comparar las PSG recientemente publicadas y revisadas para identificar cualquier deficiencia en los protocolos de estudio o los paquetes de datos. En caso de que los programas de desarrollo puedan verse afectados, los solicitantes pueden <strong>solicitar teleconferencias con la FDA <\/strong>bajo<strong> Compromisos del GDUFA III.<\/strong> Se recomienda realizar un seguimiento continuo de las listas de PSG de la FDA para anticipar futuras orientaciones relevantes para las carteras de productos.<\/p>\n<p>A medida que las expectativas regulatorias para los gen\u00e9ricos contin\u00faan evolucionando, mantenerse a la vanguardia de los borradores y pr\u00f3ximos PSG es fundamental para una planificaci\u00f3n eficiente del desarrollo. <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,<\/strong> <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> Proporciona informaci\u00f3n predictiva y procesable oportuna y automatizaci\u00f3n de extremo a extremo, lo que ayuda a los equipos a realizar un seguimiento de las actualizaciones de las directrices de la FDA, evaluar el impacto en los programas ANDA y agilizar los flujos de trabajo de cumplimiento en m\u00e1s de 160 pa\u00edses. <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.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1237118671 > .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-2070354550\">\n\n\t<div id=\"col-1286039955\" 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-1066937218\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1066937218 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW45210204 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45210204 BCX0\">Qu\u00e9\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed GrammarErrorHighlight SCXW45210204 BCX0\">son<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0Espec\u00edfico del producto de la FDA\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW45210204 BCX0\">orientaciones<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0(PSG)?<\/span><\/span><span class=\"EOP SCXW45210204 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-1245699929\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1245699929 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Los PSG de la FDA son documentos de orientaci\u00f3n que describen los dise\u00f1os de estudios recomendados y los requisitos de datos para demostrar la equivalencia terap\u00e9utica en aplicaciones de medicamentos gen\u00e9ricos.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1286039955 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1211327974\" 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 SCXW266917646 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266917646 BCX0\">\u00bfCu\u00e1ntos productos est\u00e1n cubiertos en el draft de actualizaci\u00f3n del PSG de febrero de 2026?<\/span><\/span><span class=\"EOP SCXW266917646 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-884924376\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-884924376 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">El borrador de actualizaci\u00f3n de la FDA cubre\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">98 productos<\/span><\/span><span class=\"TextRun SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">, incluyendo nuevas y revisadas\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW195383774 BCX0\">orientaciones<\/span><span class=\"NormalTextRun SCXW195383774 BCX0\">.<\/span><\/span><span class=\"EOP SCXW195383774 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-1211327974 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-184908369\" 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 SCXW234189171 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234189171 BCX0\">\u00bfQu\u00e9 tipos de productos gen\u00e9ricos est\u00e1n m\u00e1s afectados por esta actualizaci\u00f3n?<\/span><\/span><span class=\"EOP SCXW234189171 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-1747091595\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1747091595 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>La actualizaci\u00f3n afecta especialmente a <strong>productos complejos, formulaciones de liberaci\u00f3n modificada, sistemas transd\u00e9rmicos y t\u00f3picos,<\/strong> as\u00ed como productos para <strong>Trastorno por consumo de opioides y semaglutida oral. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-184908369 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-988235358\" 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 SCXW39904085 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW39904085 BCX0\">\u00bfC\u00f3mo puedo?\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW39904085 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW39904085 BCX0\">\u00a0\u00bfAyudar a los equipos a gestionar las actualizaciones de PSG de la FDA?<\/span><\/span><span class=\"EOP SCXW39904085 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-142017144\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-142017144 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> ayuda a los equipos regulatorios y de desarrollo a realizar un seguimiento de los borradores y los PSG finalizados, evaluar su impacto en los programas ANDA en curso y coordinar los flujos de trabajo regulatorios utilizando informaci\u00f3n impulsada por IA con el apoyo de expertos en el sector.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-988235358 > .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 26 de febrero de 2026, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) public\u00f3 un conjunto de borradores de gu\u00edas espec\u00edficas de productos (PSG) destinadas a apoyar el desarrollo de medicamentos gen\u00e9ricos y agilizar las aprobaciones de solicitudes abreviadas de nuevos medicamentos (ANDA) para productos farmac\u00e9uticos. Esta actualizaci\u00f3n afecta a las empresas y los equipos involucrados en el desarrollo, la presentaci\u00f3n o la revisi\u00f3n de ANDA, en particular para medicamentos gen\u00e9ricos, tanto complejos como sencillos.<\/p>","protected":false},"author":43,"featured_media":9590,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9589","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 Draft Product-Specific Guidances Overview<\/title>\n<meta name=\"description\" content=\"Explore the FDA issues regarding product-specific 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