{"id":9630,"date":"2026-03-11T15:38:40","date_gmt":"2026-03-11T07:38:40","guid":{"rendered":"https:\/\/regask.com\/?p=9630"},"modified":"2026-03-11T15:38:40","modified_gmt":"2026-03-11T07:38:40","slug":"la-fda-abre-una-consulta-publica-sobre-la-actualizacion-de-las-directrices-de-la-supac-para-los-cambios-en-la-fabricacion-de-productos-farmaceuticos-posteriores-a-la-aprobacion","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/","title":{"rendered":"La FDA abre una consulta p\u00fablica sobre la actualizaci\u00f3n de la gu\u00eda SUPAC\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">En\u00a0<\/span><b><span data-contrast=\"auto\">3 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\">\u00a0anunci\u00f3 una consulta p\u00fablica solicitando comentarios sobre su\u00a0<\/span><b><span data-contrast=\"auto\">Gu\u00edas sobre cambios posteriores a la aprobaci\u00f3n y ampliaci\u00f3n de escala (SUPAC)<\/span><\/b><span data-contrast=\"auto\">\u00a0para productos farmac\u00e9uticos. La consulta se centra en\u00a0<\/span><b><span data-contrast=\"auto\">Qu\u00edmica, fabricaci\u00f3n y controles (CMC)<\/span><\/b><span data-contrast=\"auto\">\u00a0requisitos y tiene como objetivo evaluar si los documentos de orientaci\u00f3n de SUPAC existentes siguen siendo relevantes y est\u00e1n alineados con los est\u00e1ndares cient\u00edficos y regulatorios actuales.<\/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 revisi\u00f3n cubre las directrices de SUPAC para\u00a0<\/span><b><span data-contrast=\"auto\">liberaci\u00f3n inmediata<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">versi\u00f3n modificada<\/span><\/b><span data-contrast=\"auto\">, y\u00a0<\/span><b><span data-contrast=\"auto\">formas farmac\u00e9uticas semis\u00f3lidas no est\u00e9riles<\/span><\/b><span data-contrast=\"auto\">, as\u00ed como los cambios relacionados con\u00a0<\/span><b><span data-contrast=\"auto\">equipos de fabricaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">. Se invita a las partes interesadas de toda la industria farmac\u00e9utica a enviar comentarios para ayudar a determinar si se deben incorporar revisiones, aclaraciones o temas adicionales en la gu\u00eda actualizada.<\/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 per\u00edodo de consulta permanece abierto hasta\u00a0<\/span><b><span data-contrast=\"auto\">1 de junio 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<div class=\"row\"  id=\"row-1953109975\">\n\n\t<div id=\"col-1706264185\" 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-1002197961\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1002197961 {\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-1914540046\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1914540046 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">La FDA est\u00e1 buscando comentarios sobre el\u00a0<\/span><b><span data-contrast=\"auto\">utilidad, claridad y aplicabilidad<\/span><\/b><span data-contrast=\"auto\">\u00a0de las directrices actuales de SUPAC que abordan la ampliaci\u00f3n de la fabricaci\u00f3n y los cambios posteriores a la aprobaci\u00f3n de productos farmac\u00e9uticos.<\/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 revisi\u00f3n examina espec\u00edficamente si los documentos de orientaci\u00f3n existentes para\u00a0<\/span><b><span data-contrast=\"auto\">liberaci\u00f3n inmediata<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">versi\u00f3n modificada<\/span><\/b><span data-contrast=\"auto\">, y\u00a0<\/span><b><span data-contrast=\"auto\">formas farmac\u00e9uticas semis\u00f3lidas no est\u00e9riles<\/span><\/b><span data-contrast=\"auto\">\u00a0Continuar apoyando la supervisi\u00f3n regulatoria eficaz de los cambios en el CMC. La agencia tambi\u00e9n est\u00e1 evaluando la orientaci\u00f3n relacionada con\u00a0<\/span><b><span data-contrast=\"auto\">cambios en los equipos de fabricaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">, lo que puede afectar los procesos de fabricaci\u00f3n y los sistemas de calidad.<\/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 FDA est\u00e1 considerando si estos documentos siguen alineados con los marcos regulatorios internacionales m\u00e1s recientes, particularmente\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1) sobre Gesti\u00f3n de Riesgos de Calidad<\/span><\/b><span data-contrast=\"auto\">\u00a0y\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q12 sobre la gesti\u00f3n del ciclo de vida de los productos farmac\u00e9uticos<\/span><\/b><span data-contrast=\"auto\">. La agencia alienta a las partes interesadas a identificar los desaf\u00edos en la interpretaci\u00f3n o implementaci\u00f3n de las recomendaciones de SUPAC dentro de sus actuales\u00a0<\/span><b><span data-contrast=\"auto\">sistemas de calidad farmac\u00e9utica<\/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\">Los participantes de la industria tambi\u00e9n pueden sugerir\u00a0<\/span><b><span data-contrast=\"auto\">nuevos temas, actualizaciones o revisiones<\/span><\/b><span data-contrast=\"auto\">\u00a0que podr\u00edan mejorar la pertinencia de la orientaci\u00f3n y al mismo tiempo ayudar a reducir la complejidad regulatoria o la carga innecesaria.<\/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-1706264185 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1193943926\" 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-1857046330\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1857046330 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">Se invita a las partes interesadas a\u00a0<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">entregar<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">\u00a0Comentarios sobre la revisi\u00f3n de la gu\u00eda SUPAC de la FDA por\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">1 de junio de 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\"><strong>.<\/strong> Las presentaciones podr\u00e1n realizarse a trav\u00e9s de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">canales electr\u00f3nicos o escritos especificados por la FDA<\/span><\/span><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">.<\/span><\/span><span class=\"EOP SCXW54403655 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-1193943926 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-3775421\" 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-1481855850\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1481855850 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las directrices de SUPAC desempe\u00f1an un papel importante a la hora de definir c\u00f3mo los fabricantes farmac\u00e9uticos gestionan\u00a0<\/span><b><span data-contrast=\"auto\">cambios posteriores a la aprobaci\u00f3n en los procesos de fabricaci\u00f3n y control de calidad<\/span><\/b><span data-contrast=\"auto\">. Al revisar estos documentos, la FDA busca garantizar que reflejen\u00a0<\/span><b><span data-contrast=\"auto\">est\u00e1ndares cient\u00edficos actuales, enfoques regulatorios basados en riesgos y alineaci\u00f3n con marcos internacionales<\/span><\/b><span data-contrast=\"auto\">\u00a0como\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1)<\/span><\/b><span data-contrast=\"auto\">\u00a0y\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q12<\/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\">La actualizaci\u00f3n de estas directrices puede contribuir a una mayor\u00a0<\/span><b><span data-contrast=\"auto\">Claridad regulatoria, alineaci\u00f3n digital en sistemas de calidad y gesti\u00f3n eficiente del ciclo de vida de los productos farmac\u00e9uticos<\/span><\/b><span data-contrast=\"auto\">, al tiempo que minimiza la carga regulatoria innecesaria para los fabricantes.<\/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-3775421 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-191410515\" 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-488797406\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-488797406 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">Esta consulta es especialmente relevante para\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">equipos de asuntos regulatorios, profesionales de garant\u00eda de calidad (QA), especialistas en fabricaci\u00f3n y CMC, y l\u00edderes en cumplimiento farmac\u00e9utico<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\"><strong>\u00a0<\/strong>responsable de la gesti\u00f3n\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">actividades de ampliaci\u00f3n y\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW159808703 BCX0\">postaprobaci\u00f3n<\/span><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0cambios<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0dentro de entornos de fabricaci\u00f3n farmac\u00e9utica regulados.<\/span><\/span><span class=\"EOP SCXW159808703 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-191410515 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1211488393\" 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-780134232\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-780134232 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Las organizaciones deben revisar su situaci\u00f3n actual\u00a0<\/span><b><span data-contrast=\"auto\">procedimientos internos para gestionar la ampliaci\u00f3n y los cambios de fabricaci\u00f3n posteriores a la aprobaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0contra las directrices existentes de SUPAC. Los equipos regulatorios y de calidad pueden considerar identificar \u00e1reas donde\u00a0<\/span><b><span data-contrast=\"auto\">aclaraci\u00f3n, modernizaci\u00f3n u orientaci\u00f3n adicional<\/span><\/b><span data-contrast=\"auto\">\u00a0mejorar\u00eda la implementaci\u00f3n o reducir\u00eda la complejidad operativa.<\/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 empresas tambi\u00e9n pueden beneficiarse de la coordinaci\u00f3n\u00a0<\/span><b><span data-contrast=\"auto\">retroalimentaci\u00f3n interfuncional entre los equipos regulatorios, de calidad y de fabricaci\u00f3n<\/span><\/b><span data-contrast=\"auto\">\u00a0Desarrollar una respuesta integral antes de enviar comentarios a la FDA antes de la\u00a0<\/span><b><span data-contrast=\"auto\">Fecha l\u00edmite: 1 de junio 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\">A medida que aumentan las expectativas regulatorias en torno a\u00a0<\/span><b><span data-contrast=\"auto\">Gesti\u00f3n del ciclo de vida de CMC y control de cambios basado en riesgos<\/span><\/b><span data-contrast=\"auto\">\u00a0A medida que contin\u00faan evolucionando, las herramientas de inteligencia regulatoria y monitoreo pueden ayudar a las organizaciones a rastrear consultas y anticipar posibles cambios regulatorios.<\/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> Es una plataforma l\u00edder de inteligencia regulatoria y orquestaci\u00f3n de flujos de trabajo con IA de agencia que permite a las organizaciones globales en sectores altamente regulados, como productos de consumo y ciencias de la vida, gestionar de forma proactiva entornos regulatorios complejos. Mediante la combinaci\u00f3n de... <strong>IA agente<\/strong> con expertos en el sector, <a href=\"http:\/\/regask.com\/es\/\"><strong>RegASK<\/strong><\/a> 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<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-1211488393 > .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-1747056676\">\n\n\t<div id=\"col-1086007043\" 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-361272255\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-361272255 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW116607224 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfQu\u00e9 est\u00e1 solicitando la FDA?\u00a0<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">comentario<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0\u00bfen la consulta del SUPAC?<\/span><\/span><span class=\"EOP SCXW116607224 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-1250035944\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1250035944 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">La FDA est\u00e1 solicitando comentarios p\u00fablicos sobre el<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">Relevancia, claridad y utilidad de los SUPAC existentes\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">orientaciones<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0esa direcci\u00f3n\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">ampliar y\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">postaprobaci\u00f3n<\/span><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0cambios<\/span><\/span><\/strong><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\"><strong>\u00a0<\/strong>para productos farmac\u00e9uticos, en particular en el contexto de\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">Qu\u00edmica, fabricaci\u00f3n y controles (CMC)<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">.<\/span><\/span><span class=\"EOP SCXW27174500 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-1086007043 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1595689990\" 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 SCXW185224076 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW185224076 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfQu\u00e9 categor\u00edas de productos farmac\u00e9uticos est\u00e1n cubiertas por la revisi\u00f3n de SUPAC?<\/span><\/span><span class=\"EOP SCXW185224076 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-1755743291\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1755743291 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">La consulta cubre SUPAC\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW232278638 BCX0\">orientaciones<\/span><span class=\"NormalTextRun SCXW232278638 BCX0\">\u00a0para\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">liberaci\u00f3n inmediata<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">,\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">versi\u00f3n modificada<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">, y\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">formas farmac\u00e9uticas semis\u00f3lidas no est\u00e9riles<\/span><\/span><\/strong><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\"><strong>,<\/strong> as\u00ed como orientaci\u00f3n relacionada con\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">cambios en los equipos de fabricaci\u00f3n<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">.<\/span><\/span><span class=\"EOP SCXW232278638 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-1595689990 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-160412413\" 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 SCXW132097625 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">\u00bfCu\u00e1ndo es la fecha l\u00edmite para\u00a0<\/span><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">entregar<\/span><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0\u00bfComentarios a la FDA?<\/span><\/span><span class=\"EOP SCXW132097625 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-8412221\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-8412221 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">Las partes interesadas deben\u00a0<\/span><span class=\"NormalTextRun SCXW197707949 BCX0\">entregar<\/span><span class=\"NormalTextRun SCXW197707949 BCX0\">\u00a0Comentarios sobre la revisi\u00f3n de la gu\u00eda SUPAC por\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">1 de junio de 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\"><strong>,<\/strong> utilizando el<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">Canales de presentaci\u00f3n electr\u00f3nicos o escritos especificados por la FDA<\/span><\/span><span class=\"TextRun SCXW197707949 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW197707949 BCX0\">.<\/span><\/span><span class=\"EOP SCXW197707949 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-160412413 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1004326079\" 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-1804514041\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1804514041 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/es\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW67355384 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0ayuda a los equipos regulatorios y de cumplimiento\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">monitor<\/span><strong><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0Actualizaciones regulatorias globales, analizar impactos potenciales y coordinar respuestas internas<\/span><\/strong><\/span><span class=\"TextRun SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0a consultas y revisiones de orientaci\u00f3n. Su\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">Plataforma de inteligencia regulatoria impulsada por IA de Agentic<\/span><\/span><\/strong><span class=\"TextRun SCXW67355384 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW67355384 BCX0\">\u00a0permite a las organizaciones realizar un seguimiento de los marcos regulatorios en evoluci\u00f3n, evaluar los riesgos de cumplimiento y optimizar la colaboraci\u00f3n entre los equipos regulatorios, de calidad y de fabricaci\u00f3n.<\/span><\/span><span class=\"EOP SCXW67355384 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-1004326079 > .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 3 de marzo de 2026, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) anunci\u00f3 una consulta p\u00fablica para solicitar comentarios sobre sus gu\u00edas de Ampliaci\u00f3n de Escala y Cambios Posteriores a la Aprobaci\u00f3n (SUPAC) para productos farmac\u00e9uticos. La consulta se centra en los requisitos de qu\u00edmica, fabricaci\u00f3n y controles (CMC) y tiene como objetivo evaluar si los documentos de gu\u00eda SUPAC existentes siguen siendo relevantes y est\u00e1n alineados con los est\u00e1ndares cient\u00edficos y regulatorios actuales. La revisi\u00f3n abarca las gu\u00edas SUPAC para formas farmac\u00e9uticas de liberaci\u00f3n inmediata, liberaci\u00f3n modificada y semis\u00f3lidas no est\u00e9riles\u2026<\/p>","protected":false},"author":43,"featured_media":9631,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9630","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 v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Opens Public Consultation on Pharmaceutical Changes<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s public consultation on updating SUPAC guidance for postapproval pharmaceutical manufacturing changes.\" \/>\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-abre-una-consulta-publica-sobre-la-actualizacion-de-las-directrices-de-la-supac-para-los-cambios-en-la-fabricacion-de-productos-farmaceuticos-posteriores-a-la-aprobacion\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Opens Public Consultation on Updating SUPAC Guidance for Postapproval Pharmaceutical Manufacturing Changes\" \/>\n<meta property=\"og:description\" content=\"Explore the FDA&#039;s public consultation on updating SUPAC guidance for postapproval pharmaceutical manufacturing changes.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/la-fda-abre-una-consulta-publica-sobre-la-actualizacion-de-las-directrices-de-la-supac-para-los-cambios-en-la-fabricacion-de-productos-farmaceuticos-posteriores-a-la-aprobacion\/\" \/>\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=\"2026-03-11T07:38:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.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=\"5 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"FDA Opens Public Consultation on Updating SUPAC Guidanc&hellip;\",\"datePublished\":\"2026-03-11T07:38:40+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/\"},\"wordCount\":936,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.png\",\"articleSection\":[\"United States\",\"Regulatory News\",\"Pharma and Biotech\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/\",\"name\":\"FDA Opens Public Consultation on Pharmaceutical Changes\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.png\",\"datePublished\":\"2026-03-11T07:38:40+00:00\",\"description\":\"Explore the FDA's public consultation on updating SUPAC guidance for postapproval pharmaceutical manufacturing changes.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.png\",\"width\":800,\"height\":600,\"caption\":\"Fda Opens Public Consultation Updating Supac Guidance Postapproval Pharmaceutical Manufacturing Changes\"},{\"@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 abre una consulta p\u00fablica sobre los cambios farmac\u00e9uticos","description":"Explore la consulta p\u00fablica de la FDA sobre la actualizaci\u00f3n de la gu\u00eda SUPAC para los cambios en la fabricaci\u00f3n farmac\u00e9utica posteriores a la aprobaci\u00f3n.","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-abre-una-consulta-publica-sobre-la-actualizacion-de-las-directrices-de-la-supac-para-los-cambios-en-la-fabricacion-de-productos-farmaceuticos-posteriores-a-la-aprobacion\/","og_locale":"es_ES","og_type":"article","og_title":"FDA Opens Public Consultation on Updating SUPAC Guidance for Postapproval Pharmaceutical Manufacturing Changes","og_description":"Explore the FDA's public consultation on updating SUPAC guidance for postapproval pharmaceutical manufacturing changes.","og_url":"https:\/\/regask.com\/es\/la-fda-abre-una-consulta-publica-sobre-la-actualizacion-de-las-directrices-de-la-supac-para-los-cambios-en-la-fabricacion-de-productos-farmaceuticos-posteriores-a-la-aprobacion\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-03-11T07:38:40+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.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":"5 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/#article","isPartOf":{"@id":"https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/"},"author":{"name":"Reva Ananda","@id":"https:\/\/regask.com\/#\/schema\/person\/4023a3aab44f61a84d06ca8abfcbe926"},"headline":"FDA Opens Public Consultation on Updating SUPAC Guidanc&hellip;","datePublished":"2026-03-11T07:38:40+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/"},"wordCount":936,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.png","articleSection":["United States","Regulatory News","Pharma and Biotech"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/","url":"https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/","name":"La FDA abre una consulta p\u00fablica sobre los cambios farmac\u00e9uticos","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.png","datePublished":"2026-03-11T07:38:40+00:00","description":"Explore la consulta p\u00fablica de la FDA sobre la actualizaci\u00f3n de la gu\u00eda SUPAC para los cambios en la fabricaci\u00f3n farmac\u00e9utica posteriores a la aprobaci\u00f3n.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-opens-public-consultation-updating-supac-guidance-postapproval-pharmaceutical-manufacturing-changes.png","width":800,"height":600,"caption":"Fda Opens Public Consultation Updating Supac Guidance Postapproval Pharmaceutical Manufacturing Changes"},{"@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\/9630","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=9630"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/9630\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/9631"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=9630"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=9630"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=9630"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}