{"id":8282,"date":"2025-05-27T11:49:40","date_gmt":"2025-05-27T03:49:40","guid":{"rendered":"https:\/\/regask.com\/?p=8282"},"modified":"2025-05-27T11:49:40","modified_gmt":"2025-05-27T03:49:40","slug":"regulaciones-innecesarias-de-rfi-de-la-fda-y-el-hhs-de-2025","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/hhs-fda-rfi-unnecessary-regulations-2025\/","title":{"rendered":"Solicitud de informaci\u00f3n del HHS y la FDA: Identificaci\u00f3n de..."},"content":{"rendered":"<p data-start=\"162\" data-end=\"576\">El 13 de mayo de 2025, el Departamento de Salud y Servicios Humanos de los Estados Unidos (HHS) y la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) emitieron una <strong data-start=\"291\" data-end=\"324\">Solicitud de informaci\u00f3n (RFI)<\/strong> para identificar regulaciones obsoletas, duplicadas o innecesarias. Esta medida apoya un esfuerzo federal m\u00e1s amplio para reducir las cargas regulatorias y mejorar la transparencia, de acuerdo con <strong data-start=\"504\" data-end=\"575\">Orden Ejecutiva 14192: <em data-start=\"529\" data-end=\"573\">Liberar la prosperidad mediante la desregulaci\u00f3n<\/em><\/strong>.<\/p>\n<h3 data-start=\"578\" data-end=\"609\">Un mandato desregulatorio audaz<\/h3>\n<p data-start=\"611\" data-end=\"971\">Como parte de esta iniciativa, el Secretario del HHS, Robert F. Kennedy, Jr., se ha comprometido a <strong data-start=\"695\" data-end=\"728\">Pol\u00edtica desregulatoria de \u201c10 a 1\u201d<\/strong>\u2014por cada nueva regulaci\u00f3n introducida, <strong data-start=\"766\" data-end=\"782\">al menos diez<\/strong> Las medidas regulatorias vigentes deben ser derogadas. El objetivo: reducir las cargas de cumplimiento, simplificar las operaciones de atenci\u00f3n m\u00e9dica y fomentar la innovaci\u00f3n, manteniendo al mismo tiempo los est\u00e1ndares de seguridad y eficacia.<\/p>\n<h3 data-start=\"973\" data-end=\"1009\">Componentes clave de la iniciativa<\/h3>\n<ul data-start=\"1011\" data-end=\"1542\">\n<li data-start=\"1011\" data-end=\"1109\">\n<p data-start=\"1013\" data-end=\"1109\"><strong data-start=\"1013\" data-end=\"1029\">Regla de 10 a 1<\/strong>:Por cada nueva regulaci\u00f3n se deber\u00e1n eliminar un m\u00ednimo de diez normas existentes.<\/p>\n<\/li>\n<li data-start=\"1110\" data-end=\"1226\">\n<p data-start=\"1112\" data-end=\"1226\"><strong data-start=\"1112\" data-end=\"1135\">L\u00edmite de costos regulatorios<\/strong>:El costo neto total de todas las nuevas regulaciones en el a\u00f1o fiscal 2025 debe ser <em data-start=\"1197\" data-end=\"1223\">significativamente por debajo de cero<\/em>.<\/p>\n<\/li>\n<li data-start=\"1227\" data-end=\"1386\">\n<p data-start=\"1229\" data-end=\"1386\"><strong data-start=\"1229\" data-end=\"1247\">Alcance ampliado<\/strong>:La pol\u00edtica se aplica no s\u00f3lo a las regulaciones formales, sino tambi\u00e9n a los documentos de orientaci\u00f3n, memorandos, declaraciones de pol\u00edtica y directivas similares.<\/p>\n<\/li>\n<li data-start=\"1387\" data-end=\"1542\">\n<p data-start=\"1389\" data-end=\"1542\"><strong data-start=\"1389\" data-end=\"1420\">Informes anuales de transparencia<\/strong>:HHS publicar\u00e1 actualizaciones anuales detallando qu\u00e9 regulaciones fueron modificadas o eliminadas, junto con los ahorros de costos estimados.<\/p>\n<\/li>\n<\/ul>\n<h3 data-start=\"1544\" data-end=\"1570\">Participaci\u00f3n de las partes interesadas<\/h3>\n<p data-start=\"1572\" data-end=\"1764\">La RFI invita a una amplia gama de partes interesadas (empresas, proveedores de atenci\u00f3n m\u00e9dica y el p\u00fablico en general) a aportar ideas para identificar regulaciones espec\u00edficas que est\u00e9n obsoletas o sean innecesariamente onerosas.<\/p>\n<p data-start=\"1766\" data-end=\"2016\">\ud83d\udcc4 <strong data-start=\"1769\" data-end=\"1805\">Accede a la solicitud oficial aqu\u00ed<\/strong>:<br data-start=\"1806\" data-end=\"1809\" \/><a class=\"\" href=\"https:\/\/www.federalregister.gov\/documents\/2025\/05\/14\/2025-08384\/request-for-information-rfi-ensuring-lawful-regulation-and-unleashing-innovation-to-make-american\" target=\"_new\" rel=\"noopener\" data-start=\"1809\" data-end=\"2016\">Solicitud de informaci\u00f3n \u2013 Registro Federal<\/a><\/p>\n<p data-start=\"2018\" data-end=\"2060\">\ud83d\uddd3\ufe0f <strong data-start=\"2022\" data-end=\"2045\">Fecha l\u00edmite de presentaci\u00f3n<\/strong>:12 de julio de 2025<\/p>\n<h3 data-start=\"2062\" data-end=\"2106\">Implicaciones para la industria de la salud<\/h3>\n<p data-start=\"2108\" data-end=\"2447\">Este impulso desregulatorio podr\u00eda conducir a cambios significativos en los requisitos regulatorios para varios productos de atenci\u00f3n m\u00e9dica, incluidos <strong data-start=\"2234\" data-end=\"2285\">productos farmac\u00e9uticos, dispositivos m\u00e9dicos y productos biol\u00f3gicos<\/strong>El impacto final en las estrategias de cumplimiento, los costos operativos y los plazos de aprobaci\u00f3n de productos depender\u00e1 de qu\u00e9 regulaciones se revisen o eliminen en \u00faltima instancia.<\/p>\n<h3 data-start=\"2449\" data-end=\"2476\">Pr\u00f3ximos pasos para la industria<\/h3>\n<p data-start=\"2478\" data-end=\"2613\">Las organizaciones deben evaluar sus desaf\u00edos regulatorios actuales y considerar enviar comentarios durante el per\u00edodo de consulta p\u00fablica.<\/p>\n<p data-start=\"2615\" data-end=\"2757\">\ud83d\udc49 <strong data-start=\"2618\" data-end=\"2757\">Solicite a RegASK que monitoree las actualizaciones del HHS y participe en las consultas pertinentes para mantenerse alineado con los pr\u00f3ximos cambios regulatorios.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>El 13 de mayo de 2025, el Departamento de Salud y Servicios Humanos de los Estados Unidos (HHS) y la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) emitieron una Solicitud de Informaci\u00f3n (RFI) para identificar regulaciones obsoletas, duplicadas o innecesarias. Esta iniciativa respalda un esfuerzo federal m\u00e1s amplio para reducir la carga regulatoria y mejorar la transparencia, de conformidad con la Orden Ejecutiva 14192: Liberando\u2026<\/p>","protected":false},"author":43,"featured_media":8298,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,35],"tags":[629],"class_list":["post-8282","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-biotech-latest-insights","tag-request-for-information"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.5 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>HHS and FDA Request for Information: Identifying Unnecessary Regulations | RegASK<\/title>\n<meta name=\"description\" content=\"The HHS and FDA have issued a Request for 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