{"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":"patientenzentrierte-arzneimittelentwicklung-der-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-patient-centric-drug-development\/","title":{"rendered":"US FDA: Patientenorientierte Arzneimittelentwicklung: Einbeziehung von \u2026"},"content":{"rendered":"<div>\n<div><a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">US-amerikanische FDA<\/a> vorgeschlagener Leitlinienentwurf mit dem Titel \u201ePatientenorientierte Arzneimittelentwicklung: Einbeziehung klinischer Ergebnisbewertungen in Endpunkte f\u00fcr regulatorische Entscheidungen.\u201c<\/div>\n<div><\/div>\n<div>\n<div>Der Leitlinienentwurf (Leitlinie 4) ist Teil einer Reihe von vier Dokumenten, die auf die Erhebung und \u00dcbermittlung von Patientenerfahrungsdaten und anderen relevanten Informationen f\u00fcr die Entwicklung und Regulierung von Arzneimitteln abzielen.<\/div>\n<div><\/div>\n<div>Der Zweck besteht darin:<\/div>\n<ul>\n<li>Verbesserung der Einbeziehung der klinischen Ergebnisbewertung in robuste Endpunkte f\u00fcr regulatorische Entscheidungen<\/li>\n<li>Methoden, Standards und Technologien vorschlagen, die zum Sammeln, Speichern und Analysieren von Daten aus der Patientenperspektive verwendet werden k\u00f6nnen<\/li>\n<li>Bereitstellung von Ressourcen zur Unterst\u00fctzung bei der \u00dcbermittlung von Patientenerfahrungsdaten.<\/li>\n<\/ul>\n<div>Sponsoren und andere Interessengruppen werden gebeten, bis zum 5. Juli 2023 entweder elektronische oder schriftliche Kommentare zum Leitlinienentwurf einzureichen.<\/div>\n<\/div>\n<div><\/div>\n<\/div>\n<div>M\u00f6chten Sie mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte erfahren? <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/div>\n<div><\/div>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/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>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-713580346\">\n\n\t<div id=\"col-536644185\" 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\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/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>Die US-amerikanische Arzneimittelbeh\u00f6rde FDA hat einen Leitlinienentwurf mit dem Titel \u201cPatientenorientierte Arzneimittelentwicklung: Einbeziehung klinischer Ergebnisbewertungen in die Endpunkte f\u00fcr regulatorische Entscheidungen\u201d vorgelegt. Dieser Leitlinienentwurf (Leitlinie 4) ist Teil einer vierteiligen Dokumentenreihe, die darauf abzielt, Daten zur Patientenerfahrung und andere relevante Informationen f\u00fcr die Entwicklung und Zulassung von Arzneimitteln zu sammeln und einzureichen. Der Zweck ist\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 v28.5 (Yoast SEO v28.6) - 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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