{"id":9626,"date":"2026-03-11T15:04:43","date_gmt":"2026-03-11T07:04:43","guid":{"rendered":"https:\/\/regask.com\/?p=9626"},"modified":"2026-03-11T15:04:43","modified_gmt":"2026-03-11T07:04:43","slug":"die-fda-veroffentlicht-endgultige-leitlinien-zu-nicht-interventionellen-studien-mit-real-world-daten-zur-arzneimittel-und-biologika-sicherheit","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/","title":{"rendered":"FDA ver\u00f6ffentlicht endg\u00fcltige Leitlinien zu nicht-interventionellen Studien\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">An\u00a0<\/span><b><span data-contrast=\"auto\">4. M\u00e4rz 2026<\/span><\/b><span data-contrast=\"auto\">, Die\u00a0<\/span><b><span data-contrast=\"auto\">US-amerikanische Food and Drug Administration (FDA)<\/span><\/b><span data-contrast=\"auto\">\u00a0ausgegeben\u00a0<\/span><b><span data-contrast=\"auto\">abschlie\u00dfende Leitlinien<\/span><\/b><span data-contrast=\"auto\">\u00a0die\u00a0<\/span><b><span data-contrast=\"auto\">Allgemeine Grunds\u00e4tze f\u00fcr die Planung, das Design, die Analyse und die Berichterstattung von nicht-interventionellen Studien, die Real-World-Daten (RWD) verwenden<\/span><\/b><span data-contrast=\"auto\">\u00a0zur Beurteilung der Sicherheit von Arzneimitteln. Die Leitlinien gelten f\u00fcr\u00a0<\/span><b><span data-contrast=\"auto\">Arzneimittel, Impfstoffe und biologische Produkte<\/span><\/b><span data-contrast=\"auto\">\u00a0und legt regulatorische Erwartungen fest f\u00fcr\u00a0<\/span><b><span data-contrast=\"auto\">Sicherheitsstudien nach der Markteinf\u00fchrung<\/span><\/b><span data-contrast=\"auto\">\u00a0durchgef\u00fchrt von Sponsoren aus der Pharma- und Biologika-Branche.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Das Dokument standardisiert die Durchf\u00fchrung nicht-interventioneller Studien bei der Verwendung von\u00a0<\/span><b><span data-contrast=\"auto\">Datenquellen aus der Praxis wie elektronische Patientenakten und Versicherungsanspr\u00fcche<\/span><\/b><span data-contrast=\"auto\">, Sie schafft Klarheit hinsichtlich Studiendesign, Methodik und Berichtspraxis. Sie ersetzt fr\u00fchere Leitlinienentw\u00fcrfe und\u00a0<\/span><b><span data-contrast=\"auto\">zieht die FDA-Leitlinie vom Mai 2013 zu pharmakoepidemiologischen Sicherheitsstudien unter Verwendung elektronischer Gesundheitsdatens\u00e4tze zur\u00fcck<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-1636179834\">\n\n\t<div id=\"col-557792645\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1806961042\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1806961042 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-753673911\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-753673911 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Die endg\u00fcltigen Leitlinien definieren\u00a0<\/span><b><span data-contrast=\"auto\">nicht-interventionelle Studien<\/span><\/b><span data-contrast=\"auto\">\u00a0Als Forschungsans\u00e4tze, die Ergebnisse beobachten, ohne spezifische Behandlungen oder Interventionen zuzuweisen. Diese Studien st\u00fctzen sich auf reale Daten, die im Rahmen der routinem\u00e4\u00dfigen Gesundheitsversorgung erhoben werden.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Die FDA empfiehlt Sponsoren, zun\u00e4chst Folgendes zu tun:\u00a0<\/span><b><span data-contrast=\"auto\">klare Formulierung von Forschungsfragen<\/span><\/b><span data-contrast=\"auto\">\u00a0und die Identifizierung geeigneter realer Datenquellen, die zuverl\u00e4ssige Sicherheitsbewertungen erm\u00f6glichen. Die Leitlinien betonen au\u00dferdem die Notwendigkeit,\u00a0<\/span><b><span data-contrast=\"auto\">Studienvariablen und Endpunkte pr\u00e4zise definieren<\/span><\/b><span data-contrast=\"auto\">, um sicherzustellen, dass die Datens\u00e4tze und Analysemethoden f\u00fcr die beabsichtigte Sicherheitsbewertung geeignet sind.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Dar\u00fcber hinaus hebt das Dokument die Bedeutung von\u00a0<\/span><b><span data-contrast=\"auto\">Ber\u00fccksichtigung von Verzerrungen und St\u00f6rfaktoren<\/span><\/b><span data-contrast=\"auto\">\u00a0W\u00e4hrend der Studienplanung und -analyse werden von den Sponsoren Methoden erwartet, um potenzielle Verzerrungsquellen zu identifizieren, zu bewerten und zu minimieren, die die Sicherheitsbeurteilungen beeinflussen k\u00f6nnten.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Die FDA erl\u00e4utert dar\u00fcber hinaus die Erwartungen an\u00a0<\/span><b><span data-contrast=\"auto\">transparente Studiendokumentation und umfassende Berichterstattung<\/span><\/b><span data-contrast=\"auto\">, einschlie\u00dflich detaillierter Beschreibungen der im Rahmen der Studie verwendeten Methoden, Datenquellen und Analyseverfahren.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-557792645 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-533126105\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Datum des Inkrafttretens<\/h2>\n\t<div id=\"gap-707263768\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-707263768 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">Der\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">Die endg\u00fcltige Leitlinie der FDA zu nicht-interventionellen Studien mit Real-World-Daten<\/span><\/span><\/strong><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">\u00a0wurde\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">g\u00fcltig ab <strong>4. M\u00e4rz 2026<\/strong><\/span><\/span><strong><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">.<\/span><\/span><span class=\"EOP SCXW15748117 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-533126105 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-838349249\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Warum es wichtig ist<\/h2>\n\t<div id=\"gap-1335640743\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1335640743 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">Dieses Update bietet<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">Regulatorische Klarheit f\u00fcr die Verwendung von Real-World-Daten in der Sicherheits\u00fcberwachung nach der Markteinf\u00fchrung<\/span><\/span><\/strong><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\"><strong>.<\/strong> Durch die Standardisierung von Studiendesign, Bias-Management und Berichtspraktiken unterst\u00fctzt die Leitlinie mehr\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">konsistente, zuverl\u00e4ssige und transparente Sicherheitsbewertungen<\/span><\/span><\/strong><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">\u00a0und gleichzeitig die effiziente Nutzung bestehender Datenquellen im Gesundheitswesen zu erm\u00f6glichen.<\/span><\/span><span class=\"EOP SCXW234709501 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-838349249 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1531960514\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>F\u00fcr wen ist das relevant?<\/h2>\n\t<div id=\"gap-1827361008\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1827361008 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">Die Leitlinien sind relevant f\u00fcr Teams, die an Folgendem beteiligt sind\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">\u00dcberwachung nach der Markteinf\u00fchrung und Sicherheitsbewertung<\/span><\/span><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">, <\/span><\/span><\/strong><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">einschlie\u00dflich<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">Regulatorische Angelegenheiten, Qualit\u00e4tssicherung, Patientensicherheit, Recht und Compliance, Vertrieb oder Marketing sowie F&amp;E-Funktionen<\/span><\/span><\/strong><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">\u00a0innerhalb von Pharma- und Biologika-Unternehmen.<\/span><\/span><span class=\"EOP SCXW75709743 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1531960514 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-279786741\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>N\u00e4chste Schritte<\/h2>\n\t<div id=\"gap-1828860085\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1828860085 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Organisationen, die durchf\u00fchren\u00a0<\/span><b><span data-contrast=\"auto\">nicht-interventionelle Sicherheitsstudien unter Verwendung von Daten aus der realen Welt<\/span><\/b><span data-contrast=\"auto\">\u00a0Die aktuellen Studienprotokolle und -methoden sollten \u00fcberpr\u00fcft werden, um die \u00dcbereinstimmung mit den aktualisierten Anforderungen der FDA sicherzustellen. Die Beteiligten sollten au\u00dferdem die Dokumentationspraktiken und Berichtsprozesse in den relevanten Abteilungen evaluieren, um zu best\u00e4tigen, dass Studiendesigns, Datenauswahlmethoden und Analyseverfahren den neuen Standards entsprechen.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Da die Aufsichtsbeh\u00f6rden zunehmend die Erwartungen an Real-World-Daten und die \u00dcberwachung der Arzneimittelsicherheit nach der Markteinf\u00fchrung formalisieren, k\u00f6nnen Unternehmen von Tools profitieren, die dabei helfen, die sich entwickelnden regulatorischen Vorgaben zu verfolgen und die Einhaltung auf globalen M\u00e4rkten umzusetzen.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a>\u00a0ist eine f\u00fchrende agentenbasierte KI-Plattform f\u00fcr regulatorische Intelligenz und Workflow-Orchestrierung, die globale Organisationen in stark regulierten Sektoren, darunter Konsumg\u00fcter und Biowissenschaften, in die Lage versetzt, proaktiv durch komplexe regulatorische Landschaften zu navigieren.<strong> Durch die Kombination von fortschrittlicher Agentic-KI mit Expertenwissen,\u00a0<a href=\"http:\/\/regask.com\/de\/\">RegASK<\/a><\/strong> liefert zeitnahe, vorausschauende und umsetzbare Erkenntnisse sowie eine durchg\u00e4ngige Automatisierung, optimiert Compliance-Prozesse, mindert Risiken und beschleunigt den Marktzugang in mehr als 160 L\u00e4ndern. <strong><a href=\"http:\/\/regask.com\/de\/\">Mehr erfahren<\/a> <\/strong>oder<a href=\"https:\/\/regask.com\/de\/demo-buchen\/\"><strong> Jetzt Demo buchen.<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-279786741 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1627322862\">\n\n\t<div id=\"col-1195860773\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>FAQs<\/h3>\n\t<div id=\"gap-681809937\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-681809937 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW22959475 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW22959475 BCX0\">Welche Leitlinien wird die FDA f\u00fcr 2026 zu nicht-interventionellen Studien mit Daten aus der realen Welt ver\u00f6ffentlichen?<\/span><\/span><span class=\"EOP SCXW22959475 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-719410412\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-719410412 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW182041197 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182041197 BCX0\">Die Leitlinien beschreiben\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW182041197 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182041197 BCX0\">Allgemeine Grunds\u00e4tze f\u00fcr die Planung, das Design, die Analyse und die Berichterstattung von nicht-interventionellen Studien, die realweltliche Daten verwenden.<\/span><\/span><\/strong><span class=\"TextRun SCXW182041197 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182041197 BCX0\">\u00a0um die Sicherheit von Arzneimitteln, Impfstoffen und biologischen Produkten nach der Markteinf\u00fchrung zu bewerten.<\/span><\/span><span class=\"EOP SCXW182041197 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1195860773 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1296805244\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW169711913 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW169711913 BCX0\">Welche Arten von Daten werden in diesem Leitfaden als realweltliche Daten betrachtet?<\/span><\/span><span class=\"EOP SCXW169711913 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-655021637\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-655021637 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW97422678 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97422678 BCX0\">Die FDA\u00a0<\/span><span class=\"NormalTextRun SCXW97422678 BCX0\">identifiziert<\/span><span class=\"NormalTextRun SCXW97422678 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW97422678 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97422678 BCX0\">Datenquellen wie elektronische Patientenakten und Versicherungsanspr\u00fcche<\/span><\/span><\/strong><span class=\"TextRun SCXW97422678 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97422678 BCX0\">\u00a0als Beispiele f\u00fcr reale Daten, die in nicht-interventionellen Sicherheitsstudien verwendet werden k\u00f6nnen.<\/span><\/span><span class=\"EOP SCXW97422678 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1296805244 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-196227780\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW258517632 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW258517632 BCX0\">Ersetzt diese Richtlinie\u00a0<\/span><span class=\"NormalTextRun SCXW258517632 BCX0\">vorherige<\/span><span class=\"NormalTextRun SCXW258517632 BCX0\">\u00a0Empfehlungen der FDA?<\/span><\/span><span class=\"EOP SCXW258517632 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1528132113\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1528132113 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW185775808 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185775808 BCX0\">Ja. Die endg\u00fcltige Anleitung.<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW185775808 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185775808 BCX0\">zieht die FDA-Leitlinie vom Mai 2013 zu pharmakoepidemiologischen Sicherheitsstudien unter Verwendung elektronischer Gesundheitsdatens\u00e4tze zur\u00fcck<\/span><\/span><\/strong><span class=\"TextRun SCXW185775808 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185775808 BCX0\">\u00a0und ersetzt fr\u00fchere Entwurfsempfehlungen.<\/span><\/span><span class=\"EOP SCXW185775808 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-196227780 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1968301881\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>Wie kann RegASK Unternehmen dabei helfen, regulatorische Aktualisierungen im Zusammenhang mit S\u00e4uglingsnahrung zu \u00fcberwachen?<\/h4>\n\t<div id=\"gap-1254274383\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1254274383 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW177493038 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/de\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW177493038 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW177493038 BCX0\">\u00a0hilft Organisationen\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW177493038 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW177493038 BCX0\">sich entwickelnde regulatorische Vorgaben verfolgen, Compliance-Anforderungen interpretieren und regulatorische Arbeitsabl\u00e4ufe optimieren<\/span><\/span><\/strong><span class=\"TextRun SCXW177493038 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW177493038 BCX0\"><strong>,<\/strong> dadurch in die Lage versetzt zu werden, dass Regulierungs-, Sicherheits- und Compliance-Teams effizienter auf Aktualisierungen wie die neue FDA-Leitlinie zu Real-World-Datenstudien reagieren k\u00f6nnen.<\/span><\/span><span class=\"EOP SCXW177493038 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1968301881 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Am 4. M\u00e4rz 2026 ver\u00f6ffentlichte die US-amerikanische Arzneimittelbeh\u00f6rde FDA eine endg\u00fcltige Leitlinie, die die allgemeinen Grunds\u00e4tze f\u00fcr die Planung, das Design, die Analyse und die Berichterstattung nicht-interventioneller Studien mit Real-World-Daten (RWD) zur Bewertung der Arzneimittelsicherheit darlegt. Die Leitlinie gilt f\u00fcr Arzneimittel, Impfstoffe und Biologika und definiert die regulatorischen Anforderungen an Sicherheitsstudien nach der Markteinf\u00fchrung, die von Pharma- und Biologika-Herstellern durchgef\u00fchrt werden. Das Dokument standardisiert die Durchf\u00fchrung nicht-interventioneller Studien\u2026<\/p>","protected":false},"author":43,"featured_media":9627,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9626","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-pharma-biotech-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 Issues Final Guidance on Non-Interventional Studies<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s final guidance on non-interventional studies using real-world data for drug and biologic safety assessments.\" \/>\n<meta name=\"robots\" content=\"index, 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