{"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":"developpement-de-medicaments-centre-sur-le-patient-par-la-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-patient-centric-drug-development\/","title":{"rendered":"FDA am\u00e9ricaine : D\u00e9veloppement de m\u00e9dicaments ax\u00e9 sur le patient : int\u00e9gration\u2026"},"content":{"rendered":"<div>\n<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">FDA des \u00c9tats-Unis<\/a> projet de ligne directrice intitul\u00e9 \u00ab D\u00e9veloppement de m\u00e9dicaments ax\u00e9 sur le patient : int\u00e9gration des \u00e9valuations des r\u00e9sultats cliniques dans les crit\u00e8res d\u2019\u00e9valuation pour la prise de d\u00e9cision r\u00e9glementaire \u00bb.<\/div>\n<div><\/div>\n<div>\n<div>Le projet de document d&#039;orientation (Guidance 4) fait partie d&#039;une s\u00e9rie de quatre documents visant \u00e0 collecter et \u00e0 soumettre des donn\u00e9es sur l&#039;exp\u00e9rience des patients et d&#039;autres informations pertinentes pour le d\u00e9veloppement et la r\u00e9glementation des m\u00e9dicaments.<\/div>\n<div><\/div>\n<div>Le but est de :<\/div>\n<ul>\n<li>am\u00e9liorer l&#039;inclusion de l&#039;\u00e9valuation des r\u00e9sultats cliniques dans des crit\u00e8res d&#039;\u00e9valuation robustes pour la prise de d\u00e9cision r\u00e9glementaire<\/li>\n<li>proposer des m\u00e9thodologies, des normes et des technologies qui peuvent \u00eatre utilis\u00e9es pour collecter, stocker et analyser les donn\u00e9es du point de vue des patients<\/li>\n<li>fournir des ressources pour aider \u00e0 la soumission des donn\u00e9es sur l\u2019exp\u00e9rience des patients.<\/li>\n<\/ul>\n<div>Les sponsors et autres parties prenantes sont encourag\u00e9s \u00e0 soumettre des commentaires \u00e9lectroniques ou \u00e9crits sur le projet d\u2019orientation avant le 5 juillet 2023.<\/div>\n<\/div>\n<div><\/div>\n<\/div>\n<div>Besoin d\u2019en savoir plus sur les changements r\u00e9glementaires relatifs aux dispositifs m\u00e9dicaux ? <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/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>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-33428224\">\n\n\t<div id=\"col-1258651358\" 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\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/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 am\u00e9ricaine a propos\u00e9 un projet de lignes directrices intitul\u00e9 \u00ab D\u00e9veloppement de m\u00e9dicaments ax\u00e9 sur le patient : int\u00e9gration des \u00e9valuations des r\u00e9sultats cliniques dans les crit\u00e8res d\u2019\u00e9valuation pour la prise de d\u00e9cision r\u00e9glementaire \u00bb. Le projet de document d\u2019orientation (Guidance 4) fait partie d\u2019une s\u00e9rie de quatre documents visant \u00e0 recueillir et \u00e0 soumettre des donn\u00e9es sur l\u2019exp\u00e9rience des patients et d\u2019autres informations pertinentes pour le d\u00e9veloppement et la r\u00e9glementation des produits m\u00e9dicinaux. L\u2019objectif est de\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 v27.6 (Yoast SEO v27.6) - 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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