{"id":7950,"date":"2025-01-08T20:33:04","date_gmt":"2025-01-08T12:33:04","guid":{"rendered":"https:\/\/regask.com\/?p=7950"},"modified":"2025-01-08T20:33:04","modified_gmt":"2025-01-08T12:33:04","slug":"reunion-sobre-medicamentos-pediatricos-de-la-fda-de-ee-uu","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/us-fda-pediatric-drug-meeting\/","title":{"rendered":"La FDA de EE. UU. anuncia una reuni\u00f3n p\u00fablica sobre legislaci\u00f3n pedi\u00e1trica\u2026"},"content":{"rendered":"<p>El <strong><a href=\"https:\/\/regask.com\/es\/desarrollo-de-medicamentos-centrados-en-el-paciente-por-parte-de-la-fda\/\">Administraci\u00f3n de Alimentos y Medicamentos<\/a> (FDA)<\/strong> ha programado una reuni\u00f3n p\u00fablica titulada <strong>\u201cReuni\u00f3n de partes interesadas: Implementaci\u00f3n de la Ley de Mejores Productos Farmac\u00e9uticos para Ni\u00f1os (BPCA, por sus siglas en ingl\u00e9s) y la Ley de Equidad en la Investigaci\u00f3n Pedi\u00e1trica (PREA, por sus siglas en ingl\u00e9s)\u201d<\/strong> en <strong>15 de mayo de 2025<\/strong>Este evento brindar\u00e1 una plataforma para que las partes interesadas discutan el impacto de la legislaci\u00f3n pedi\u00e1trica en el desarrollo de medicamentos y productos biol\u00f3gicos, dando forma a los avances futuros en la atenci\u00f3n m\u00e9dica pedi\u00e1trica.<\/p>\n<h4><strong>Objetivos de la reuni\u00f3n:<\/strong><\/h4>\n<p>La FDA busca aportes de diversas partes interesadas, incluidos grupos de pacientes, cuidadores, representantes de la industria y el mundo acad\u00e9mico, para:<\/p>\n<ol>\n<li><strong>Evaluar el impacto en la salud p\u00fablica:<\/strong> Examine c\u00f3mo BPCA y PREA han influido en las opciones de tratamiento pedi\u00e1trico y han abordado necesidades m\u00e9dicas no satisfechas.<\/li>\n<li><strong>Incentivos y requisitos de equilibrio:<\/strong> Explore c\u00f3mo los incentivos bajo la BPCA y los mandatos de estudio bajo la PREA afectan los planes de desarrollo de medicamentos.<\/li>\n<li><strong>Identificar barreras:<\/strong> Analice desaf\u00edos como la infraestructura de los ensayos cl\u00ednicos, la diversidad de inscripci\u00f3n y los obst\u00e1culos que impiden la finalizaci\u00f3n del estudio.<\/li>\n<li><strong>Aproveche los avances cient\u00edficos:<\/strong> Destacar enfoques innovadores como la extrapolaci\u00f3n pedi\u00e1trica, los dise\u00f1os de ensayos adaptativos, los biomarcadores como sustitutos y los datos del mundo real para mejorar la generaci\u00f3n de evidencia para las poblaciones pedi\u00e1tricas.<\/li>\n<li><strong>Mejorar la alineaci\u00f3n global:<\/strong> Abordar la importancia de la colaboraci\u00f3n internacional en el desarrollo de medicamentos pedi\u00e1tricos.<\/li>\n<\/ol>\n<h4><strong>Detalles del evento:<\/strong><\/h4>\n<ul>\n<li><strong>Fecha:<\/strong> 15 de mayo de 2025<\/li>\n<li><strong>Tiempo:<\/strong> 9:00 am \u2013 4:30 pm hora del este<\/li>\n<li><strong>Ubicaci\u00f3n:<\/strong>\n<ul>\n<li><strong>Pr\u00e1cticamente<\/strong><\/li>\n<li><strong>In situ:<\/strong> Campus de la FDA en White Oak, 10903 New Hampshire Ave., edificio 31, centro de conferencias, gran sal\u00f3n White Oak, Silver Spring, MD 20993-0002<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h4><strong>C\u00f3mo participar:<\/strong><\/h4>\n<ul>\n<li>Se anima a las partes interesadas a asistir a la reuni\u00f3n y compartir sus experiencias relacionadas con BPCA y PREA.<\/li>\n<li>Los comentarios electr\u00f3nicos o escritos sobre la reuni\u00f3n deben enviarse por <strong>13 de junio de 2025<\/strong>.<\/li>\n<\/ul>\n<h4><strong>Impacto en el desarrollo de medicamentos pedi\u00e1tricos:<\/strong><\/h4>\n<p>Esta reuni\u00f3n p\u00fablica influir\u00e1 en las estrategias para el desarrollo de medicamentos y productos biol\u00f3gicos pedi\u00e1tricos, haciendo hincapi\u00e9 en \u00e1reas con grandes necesidades m\u00e9dicas no satisfechas. El enfoque de la FDA en el aprovechamiento de metodolog\u00edas cient\u00edficas avanzadas, como datos del mundo real, ensayos adaptativos y extrapolaci\u00f3n pedi\u00e1trica, ofrece una oportunidad para que las partes interesadas alineen sus planes de desarrollo con las cambiantes expectativas regulatorias.<\/p>\n<p>Esta reuni\u00f3n refleja la <a href=\"https:\/\/regask.com\/es\/interfaz-tipo-iron-man-aprobada-por-la-fda-para-dispositivos-medicos\/\">El compromiso de la FDA<\/a> para promover la atenci\u00f3n sanitaria pedi\u00e1trica mediante la colaboraci\u00f3n, la innovaci\u00f3n y marcos regulatorios s\u00f3lidos.<\/p>","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration (FDA) has scheduled a public meeting titled \u201cInterested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act (BPCA) and Paediatric Research Equity Act (PREA)\u201d on May 15, 2025. This event will provide a platform for stakeholders to discuss the impact of paediatric legislation on drug and biologic development, shaping&#8230;<\/p>","protected":false},"author":30,"featured_media":7955,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,35],"tags":[165,617],"class_list":["post-7950","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-biotech-latest-insights","tag-public-health","tag-biologics-regulation"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US FDA to Host Meeting on Pediatric Drug Development | RegASK<\/title>\n<meta name=\"description\" content=\"US FDA announces a public meeting on pediatric drug development, focusing on BPCA, &amp; PREA. 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