{"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-913954682\">\n\n\t<div id=\"col-713363985\" 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>US FDA proposed draft guidance titled &#8220;Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.&#8221; The draft guidance document (Guidance 4) is part of a series of four documents aimed at collecting and submitting patient experience data and other relevant information for the development and regulation of medicinal products The purpose is&#8230;<\/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 v27.3 (Yoast SEO v27.4) - 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. Learn how clinical outcome assessments (COAs) shape regulatory decisions.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/patientenzentrierte-arzneimittelentwicklung-der-fda\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making\" \/>\n<meta property=\"og:description\" content=\"The FDA emphasizes patient experience in drug development. Learn how clinical outcome assessments (COAs) shape regulatory decisions.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/patientenzentrierte-arzneimittelentwicklung-der-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\u00a0Minute\" \/>\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\":\"de\"},{\"@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. Learn how clinical outcome assessments (COAs) shape regulatory decisions.\",\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-patient-centric-drug-development\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"width\":689,\"height\":626,\"caption\":\"fda\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"de\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA priorisiert Patientenmeinung bei Arzneimittelzulassungen | RegASK","description":"Die FDA legt bei der Arzneimittelentwicklung Wert auf die Patientenerfahrung. Erfahren Sie, wie klinische Ergebnisbewertungen (COAs) regulatorische Entscheidungen beeinflussen.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/de\/patientenzentrierte-arzneimittelentwicklung-der-fda\/","og_locale":"de_DE","og_type":"article","og_title":"US FDA: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making","og_description":"The FDA emphasizes patient experience in drug development. Learn how clinical outcome assessments (COAs) shape regulatory decisions.","og_url":"https:\/\/regask.com\/de\/patientenzentrierte-arzneimittelentwicklung-der-fda\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2023-04-26T01:48:57+00:00","article_modified_time":"2024-11-21T20:44:55+00:00","og_image":[{"width":689,"height":626,"url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Benoit Trouwaert","Est. reading time":"1\u00a0Minute"},"schema":{"@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":"de"},{"@type":"WebPage","@id":"https:\/\/regask.com\/fda-patient-centric-drug-development\/","url":"https:\/\/regask.com\/fda-patient-centric-drug-development\/","name":"FDA priorisiert Patientenmeinung bei Arzneimittelzulassungen | 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":"Die FDA legt bei der Arzneimittelentwicklung Wert auf die Patientenerfahrung. Erfahren Sie, wie klinische Ergebnisbewertungen (COAs) regulatorische Entscheidungen beeinflussen.","inLanguage":"de","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/fda-patient-centric-drug-development\/"]}]},{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/regask.com\/fda-patient-centric-drug-development\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png","width":689,"height":626,"caption":"fda"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Intelligentere Regulierungsentscheidungen erm\u00f6glichen","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"de","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Benoit Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts\/4234","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/comments?post=4234"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/posts\/4234\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/media\/2976"}],"wp:attachment":[{"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/media?parent=4234"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/categories?post=4234"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/de\/wp-json\/wp\/v2\/tags?post=4234"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}