{"id":7921,"date":"2024-12-20T19:29:03","date_gmt":"2024-12-20T11:29:03","guid":{"rendered":"https:\/\/regask.com\/?p=7921"},"modified":"2024-12-20T19:29:03","modified_gmt":"2024-12-20T11:29:03","slug":"centro-de-evidencia-del-mundo-real-de-la-fda-de-ee-uu","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/us-fda-real-world-evidence-center\/","title":{"rendered":"La FDA (EE. UU.) establece un nuevo centro para la evidencia del mundo real\u2026"},"content":{"rendered":"<p>En <strong>12 de diciembre de 2024<\/strong>La Administraci\u00f3n de Alimentos y Medicamentos de Estados Unidos (FDA) anunci\u00f3 la creaci\u00f3n de la <em>Centro de evidencia e innovaci\u00f3n en el mundo real (CRWEI)<\/em> dentro del Centro de Evaluaci\u00f3n e Investigaci\u00f3n de Medicamentos (CDER). Esto marca un paso importante en la mejora de la capacidad de la FDA para integrar <a href=\"https:\/\/regask.com\/es\/evidencia-del-mundo-real-sobre-afirmaciones-de-venta-libre\/\"><strong>evidencia del mundo real (RWE)<\/strong><\/a> en los procesos de evaluaci\u00f3n de medicamentos. Aprovechando los datos del mundo real (RWD), el CRWEI tiene como objetivo mejorar la evaluaci\u00f3n de la seguridad y eficacia de los medicamentos, y la vigilancia posterior a su comercializaci\u00f3n.<\/p>\n<p>La creaci\u00f3n de este centro subraya el compromiso de la FDA de modernizar los marcos regulatorios para adaptarse a las metodolog\u00edas cient\u00edficas en evoluci\u00f3n. Se centrar\u00e1 en promover el uso de la evidencia cient\u00edfica en la toma de decisiones regulatorias, garantizando que los productos terap\u00e9uticos cumplan con altos est\u00e1ndares de seguridad y eficacia y, al mismo tiempo, acelerando el acceso a tratamientos innovadores.<\/p>\n<p>Una prioridad clave para el CRWEI es fomentar <strong>colaboraci\u00f3n<\/strong> con partes interesadas externas, como el mundo acad\u00e9mico, la industria y otras agencias gubernamentales, para impulsar la innovaci\u00f3n en las metodolog\u00edas de investigaci\u00f3n de RWE. Al agilizar la integraci\u00f3n de RWE en las pr\u00e1cticas regulatorias, el centro desempe\u00f1ar\u00e1 un papel fundamental en la formulaci\u00f3n de pol\u00edticas en diversas \u00e1reas terap\u00e9uticas y en la orientaci\u00f3n de las expectativas de cumplimiento para las compa\u00f1\u00edas farmac\u00e9uticas.<\/p>\n<p>La creaci\u00f3n del CRWEI representa un cambio m\u00e1s amplio hacia <strong>Regulaci\u00f3n de la atenci\u00f3n sanitaria basada en datos<\/strong>, lo que indica posibles cambios para las compa\u00f1\u00edas farmac\u00e9uticas en la presentaci\u00f3n de evidencia para las aprobaciones de medicamentos y los compromisos posteriores a la comercializaci\u00f3n. Se alienta a las partes interesadas de la industria a que sigan de cerca las nuevas pautas, adapten las estrategias de presentaci\u00f3n y participen en la investigaci\u00f3n colaborativa de RWE para alinearse con las expectativas regulatorias cambiantes.<\/p>\n<p>Se espera que esta iniciativa tenga un impacto positivo en el ecosistema de atenci\u00f3n m\u00e9dica al acelerar el acceso a tratamientos que salvan vidas y al mismo tiempo mantener est\u00e1ndares rigurosos de seguridad y eficacia de los medicamentos.<\/p>","protected":false},"excerpt":{"rendered":"<p>On December 12, 2024, the U.S. Food and Drug Administration (FDA) announced the creation of the Center for Real-World Evidence and Innovation (CRWEI) within the Center for Drug Evaluation and Research (CDER). This marks a significant step in enhancing the FDA\u2019s ability to integrate real-world evidence (RWE) into drug evaluation processes. By leveraging real-world data&#8230;<\/p>","protected":false},"author":43,"featured_media":7938,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,35],"tags":[225,387],"class_list":["post-7921","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-biotech-latest-insights","tag-drug-safety","tag-real-word-evidence-rwe"],"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>US FDA&#039;s Center for Real-World Evidence Innovation | RegASK<\/title>\n<meta name=\"description\" content=\"US FDA launches a center to advance real-world evidence for drug safety and efficacy. 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