{"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-258531065\">\n\n\t<div id=\"col-1796138056\" 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-610327773\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-610327773 {\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-1149409719\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1149409719 {\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-1796138056 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-885336955\" 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-1155900111\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1155900111 {\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-885336955 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1710916242\" 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-828780337\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-828780337 {\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-1710916242 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-43692373\" 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-2129714221\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2129714221 {\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-43692373 > .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-1917423013\">\n\n\t<div id=\"col-841595479\" 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-390202902\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-390202902 {\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-607388260\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-607388260 {\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-841595479 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2081657191\" 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-689692844\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-689692844 {\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-2081657191 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-973049227\" 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-1313344484\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1313344484 {\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-973049227 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1795665269\" 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-1798905842\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1798905842 {\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-1795665269 > .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 February 26, 2026, the U.S. Food and Drug Administration (FDA) published a batch of draft product-specific guidances (PSGs) aimed at supporting generic drug development and streamlining Abbreviated New Drug Application (ANDA) approvals for pharmaceuticals. The update affects companies and teams involved in developing, submitting, or reviewing ANDAs, particularly for both complex and non-complex generic&#8230;<\/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 v27.6 (Yoast SEO v27.6) - 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 guidances to support generic drug development and ANDA approvals in 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