{"id":4234,"date":"2023-04-26T09:48:57","date_gmt":"2023-04-26T01:48:57","guid":{"rendered":"https:\/\/regask.com\/?p=4234"},"modified":"2024-11-22T04:44:55","modified_gmt":"2024-11-21T20:44:55","slug":"desarrollo-de-medicamentos-centrados-en-el-paciente-por-parte-de-la-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-patient-centric-drug-development\/","title":{"rendered":"FDA de EE. UU.: Desarrollo de medicamentos centrado en el paciente: incorporaci\u00f3n\u2026"},"content":{"rendered":"<div>\n<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">FDA de EE.UU.<\/a> Proyecto de orientaci\u00f3n propuesto titulado \u201cDesarrollo de f\u00e1rmacos centrado en el paciente: incorporaci\u00f3n de evaluaciones de resultados cl\u00ednicos en los criterios de valoraci\u00f3n para la toma de decisiones regulatorias\u201d.<\/div>\n<div><\/div>\n<div>\n<div>El proyecto de documento de orientaci\u00f3n (Orientaci\u00f3n 4) forma parte de una serie de cuatro documentos destinados a recopilar y presentar datos sobre la experiencia de los pacientes y otra informaci\u00f3n relevante para el desarrollo y la regulaci\u00f3n de los medicamentos.<\/div>\n<div><\/div>\n<div>El prop\u00f3sito es:<\/div>\n<ul>\n<li>Mejorar la inclusi\u00f3n de la evaluaci\u00f3n de resultados cl\u00ednicos en criterios de valoraci\u00f3n s\u00f3lidos para la toma de decisiones regulatorias.<\/li>\n<li>Sugerir metodolog\u00edas, est\u00e1ndares y tecnolog\u00edas que se puedan utilizar para recopilar, almacenar y analizar datos de la perspectiva del paciente.<\/li>\n<li>Proporcionar recursos para ayudar con el env\u00edo de datos sobre la experiencia del paciente.<\/li>\n<\/ul>\n<div>Se alienta a los patrocinadores y otras partes interesadas a enviar comentarios electr\u00f3nicos o escritos sobre el borrador de la gu\u00eda antes del 5 de julio de 2023.<\/div>\n<\/div>\n<div><\/div>\n<\/div>\n<div>\u00bfNecesita saber m\u00e1s sobre los cambios en la regulaci\u00f3n de dispositivos m\u00e9dicos? <a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" rel=\"noopener\">Ponte en contacto con los expertos de RegASK.<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/patient-focused-drug-development-incorporating-clinical-outcome-assessments-endpoints-regulatory\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-712018312\">\n\n\t<div id=\"col-1278778289\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-casos-de-estudio-dispositivos-medicos\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria de dispositivos m\u00e9dicos<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>La FDA de EE. UU. propuso un borrador de gu\u00eda titulado \u201cDesarrollo de medicamentos centrado en el paciente: incorporaci\u00f3n de evaluaciones de resultados cl\u00ednicos en los criterios de valoraci\u00f3n para la toma de decisiones regulatorias\u201d. El borrador del documento de gu\u00eda (Gu\u00eda 4) es parte de una serie de cuatro documentos destinados a recopilar y presentar datos sobre la experiencia de los pacientes y otra informaci\u00f3n relevante para el desarrollo y la regulaci\u00f3n de productos medicinales. El prop\u00f3sito es\u2026<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4234","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Prioritizes Patient Voice in Drug Approvals | RegASK<\/title>\n<meta name=\"description\" content=\"The FDA emphasizes patient experience in drug development. 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Learn how clinical outcome assessments (COAs) shape regulatory decisions.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/desarrollo-de-medicamentos-centrados-en-el-paciente-por-parte-de-la-fda\/\" \/>\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=\"2023-04-26T01:48:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T20:44:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\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=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA: Patient-Focused Drug Development: Incorporating&hellip;\",\"datePublished\":\"2023-04-26T01:48:57+00:00\",\"dateModified\":\"2024-11-21T20:44:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/\"},\"wordCount\":210,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/\",\"name\":\"FDA Prioritizes Patient Voice in Drug Approvals | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"datePublished\":\"2023-04-26T01:48:57+00:00\",\"dateModified\":\"2024-11-21T20:44:55+00:00\",\"description\":\"The FDA emphasizes patient experience in drug development. 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