{"id":9620,"date":"2026-03-11T14:41:45","date_gmt":"2026-03-11T06:41:45","guid":{"rendered":"https:\/\/regask.com\/?p=9620"},"modified":"2026-03-11T15:50:07","modified_gmt":"2026-03-11T07:50:07","slug":"die-fda-veroffentlicht-einen-leitlinienentwurf-zur-dreijahrigen-exklusivitat-klinischer-prufungen-fur-ndas-und-nahrungserganzungsmittel","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/","title":{"rendered":"FDA ver\u00f6ffentlicht Entwurf einer Leitlinie zu dreij\u00e4hrigen klinischen 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\">\u00a0ver\u00f6ffentlichte ein\u00a0<\/span><b><span data-contrast=\"auto\">Entwurf eines Leitfadens<\/span><\/b><span data-contrast=\"auto\">\u00a0Adressierung\u00a0<\/span><b><span data-contrast=\"auto\">dreij\u00e4hrige Exklusivit\u00e4t f\u00fcr klinische Pr\u00fcfungen<\/span><\/b><span data-contrast=\"auto\">\u00a0f\u00fcr Arzneimittel. Die Leitlinie verdeutlicht die regulatorischen Erwartungen an Antragsteller, die Exklusivit\u00e4t f\u00fcr folgende Produkte anstreben:\u00a0<\/span><b><span data-contrast=\"auto\">Zulassungsantr\u00e4ge f\u00fcr neue Arzneimittel (NDAs)<\/span><\/b><span data-contrast=\"auto\">\u00a0Und\u00a0<\/span><b><span data-contrast=\"auto\">NDA-Erg\u00e4nzungen<\/span><\/b><span data-contrast=\"auto\">, insbesondere wenn neue klinische Untersuchungen diese Antr\u00e4ge st\u00fctzen.<\/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\">Der Entwurf der Leitlinien soll Antragstellern helfen, die\u00a0<\/span><b><span data-contrast=\"auto\">gesetzliche und aufsichtsrechtliche Zulassungskriterien<\/span><\/b><span data-contrast=\"auto\">\u00a0erforderlich zu erhalten\u00a0<\/span><b><span data-contrast=\"auto\">3 Jahre Exklusivit\u00e4t<\/span><\/b><span data-contrast=\"auto\">. Es enth\u00e4lt au\u00dferdem Empfehlungen zu folgenden Punkten:\u00a0<\/span><b><span data-contrast=\"auto\">Inhalt und Format von Exklusivit\u00e4tsanfragen<\/span><\/b><span data-contrast=\"auto\">, pr\u00e4sentiert in einer strukturierten\u00a0<\/span><b><span data-contrast=\"auto\">Frage-Antwort-Format<\/span><\/b><span data-contrast=\"auto\">. Das Dokument liegt derzeit bis auf Weiteres zur \u00f6ffentlichen Kommentierung aus.\u00a0<\/span><b><span data-contrast=\"auto\">4. Mai 2026<\/span><\/b><span data-contrast=\"auto\">, Anschlie\u00dfend wird die FDA das Feedback der Interessengruppen pr\u00fcfen, bevor sie die Leitlinien endg\u00fcltig festlegt.<\/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-833508357\">\n\n\t<div id=\"col-384855436\" 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-1134124722\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1134124722 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-93393620\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-93393620 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Der Leitlinienentwurf beschreibt\u00a0<\/span><b><span data-contrast=\"auto\">Dokumentationsstandards<\/span><\/b><span data-contrast=\"auto\">\u00a0dass Antragsteller bei der Beantragung Folgendes beachten sollten\u00a0<\/span><b><span data-contrast=\"auto\">dreij\u00e4hrige klinische Pr\u00fcfung der Exklusivit\u00e4t<\/span><\/b><span data-contrast=\"auto\">. Es enth\u00e4lt detaillierte Empfehlungen, wie die zur Unterst\u00fctzung eines Exklusivit\u00e4tsantrags erforderlichen Informationen im Rahmen der Einreichung eines Geheimhaltungsvertrags (NDA) oder einer Erg\u00e4nzung zum Geheimhaltungsvertrag (NDA) pr\u00e4sentiert werden k\u00f6nnen.<\/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 Richtlinien gelten f\u00fcr beide\u00a0<\/span><b><span data-contrast=\"auto\">urspr\u00fcngliche Geheimhaltungsvereinbarungen<\/span><\/b><span data-contrast=\"auto\">\u00a0Und\u00a0<\/span><b><span data-contrast=\"auto\">NDA-Erg\u00e4nzungen<\/span><\/b><span data-contrast=\"auto\">\u00a0die sich darauf verlassen\u00a0<\/span><b><span data-contrast=\"auto\">neue klinische Studien<\/span><\/b><span data-contrast=\"auto\">. Durch die Klarstellung der Erwartungen hinsichtlich Format und erforderlicher Begleitinformationen zielt die FDA darauf ab, die Einheitlichkeit bei der Einreichung von Exklusivit\u00e4tsantr\u00e4gen zu verbessern.<\/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 weist die Beh\u00f6rde darauf hin, dass die Leitlinien auch weiterhin weiterentwickelt werden.\u00a0<\/span><b><span data-contrast=\"auto\">Zuk\u00fcnftige Aktualisierungen k\u00f6nnen weitere Fragen und Antworten enthalten.<\/span><\/b><span data-contrast=\"auto\">\u00a0wenn neue regulatorische Rahmenbedingungen entstehen und R\u00fcckmeldungen von Interessengruppen ber\u00fccksichtigt 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\t\t<\/div>\n\t\t\t\t\n<style>\n#col-384855436 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-886958213\" 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>Feedback-Frist<\/h2>\n\t<div id=\"gap-1066564646\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1066564646 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">Interessengruppen k\u00f6nnten\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">einreichen<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u00a0Kommentare zu\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">FDA-Leitlinienentwurf\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">hinsichtlich<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\"> dreij\u00e4hrige Exklusivit\u00e4t f\u00fcr klinische Pr\u00fcfungen\u00a0<\/span><\/span><\/strong><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">bis <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">4. Mai 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\"><strong>.<\/strong> Kommentare k\u00f6nnen sein\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">eingereicht<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u00a0durch die FDA\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">Online- oder schriftliche Einreichungskan\u00e4le<\/span><\/span><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">.<\/span><\/span><span class=\"EOP SCXW57646166 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-886958213 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-987031909\" 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-1948747503\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1948747503 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">Der Leitlinienentwurf bietet mehr\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">regulatorische Klarheit<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u00a0rund um die Zulassungsvoraussetzungen und Dokumentationsanforderungen f\u00fcr\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">dreij\u00e4hrige Datenexklusivit\u00e4t<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u00a0im Zusammenhang mit Arzneimittelzulassungen in den Vereinigten Staaten. Klarere Erwartungen k\u00f6nnen die Vorbereitung der Einreichung optimieren und unterst\u00fctzen.<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">regulatorische Konsistenz<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\"><strong>,<\/strong> und die Unsicherheit f\u00fcr Sponsoren zu verringern, die NDAs oder Erg\u00e4nzungen vorbereiten, die durch neue klinische Pr\u00fcfungen unterst\u00fctzt werden.<\/span><\/span><span class=\"EOP SCXW213098303 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-987031909 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1786430093\" 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-608795264\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-608795264 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">Dieses Update ist besonders relevant f\u00fcr\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">Pharmahersteller, Sponsoren klinischer Studien, Zulassungsteams und Compliance-Experten<\/span><\/span><\/strong><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">\u00a0verantwortlich f\u00fcr die Vorbereitung\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\"><strong>NDA-Einreichungen oder Erg\u00e4nzungen, die durch klinische Studien unterst\u00fctzt werden<\/strong><\/span><\/span><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\"><strong>.<\/strong> Organisationen, die an der Arzneimittelentwicklung und den Zulassungsverfahren in den USA beteiligt sind, sollten den Entwurf der Leitlinie pr\u00fcfen, um deren Auswirkungen auf Exklusivit\u00e4tsantr\u00e4ge zu verstehen.<\/span><\/span><span class=\"EOP SCXW4282818 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-1786430093 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1924342367\" 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-1989874187\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1989874187 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Die zust\u00e4ndigen Regulierungsbeh\u00f6rden sollten die\u00a0<\/span><b><span data-contrast=\"auto\">Entwurf einer FDA-Leitlinie zur dreij\u00e4hrigen Exklusivit\u00e4t klinischer Pr\u00fcfungen<\/span><\/b><span data-contrast=\"auto\">\u00a0und beurteilen Sie, wie sich dies auswirken k\u00f6nnte.\u00a0<\/span><b><span data-contrast=\"auto\">aktuelle oder geplante NDA- und NDA-Erg\u00e4nzungsantr\u00e4ge<\/span><\/b><span data-contrast=\"auto\">. Die Beteiligten k\u00f6nnen auch erw\u00e4gen, Kommentare, Feedback oder Kl\u00e4rungsfragen vorzubereiten und vor der Sitzung einzureichen.\u00a0<\/span><b><span data-contrast=\"auto\">Einsendeschluss f\u00fcr Kommentare: 4. Mai 2026<\/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<p><span data-contrast=\"auto\">Organisationen, die mehrere regulatorische Einreichungen in verschiedenen M\u00e4rkten verwalten, k\u00f6nnen auch von zentralisierten Tools f\u00fcr regulatorische Informationen profitieren, die dabei helfen, sich entwickelnde Richtlinien und Erwartungen an die Einreichung zu verfolgen.<\/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 ein f\u00fchrender\u00a0<\/span><b><span data-contrast=\"auto\">Agentic AI-Plattform f\u00fcr regulatorische Intelligenz und Workflow-Orchestrierung<\/span><\/b><span data-contrast=\"auto\">\u00a0Das System erm\u00f6glicht es globalen Organisationen in stark regulierten Branchen, darunter Konsumg\u00fcter und Biowissenschaften, sich proaktiv in komplexen regulatorischen Umfeldern zu bewegen. Durch die Kombination fortschrittlicher Technologien\u00a0<\/span><b><span data-contrast=\"auto\">Agentische KI<\/span><\/b><span data-contrast=\"auto\">\u00a0mit Einbindung von Experten,\u00a0<a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a>\u00a0liefert zeitnahe, vorausschauende und umsetzbare Erkenntnisse sowie eine durchg\u00e4ngige Automatisierung, optimiert Compliance-Prozesse, mindert Risiken und beschleunigt den Marktzugang in mehr als\u00a0<\/span><b><span data-contrast=\"auto\">160 L\u00e4nder<\/span><\/b><span data-contrast=\"auto\">. <a href=\"http:\/\/regask.com\/de\/\"><strong>Mehr erfahren <\/strong><\/a>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-1924342367 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-509987719\" 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-967303664\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-967303664 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Die Beteiligten sollten die <strong>Aktualisierte Webressourcen der FDA zu S\u00e4uglingsnahrung<\/strong> und die neuen <strong>ver\u00f6ffentlichte Marktliste<\/strong> um sicherzustellen, dass interne Aufzeichnungen und \u00f6ffentlich zug\u00e4ngliche Produktinformationen aufeinander abgestimmt sind.<\/p>\n<p>Die Teams f\u00fcr Regulierung, Qualit\u00e4tssicherung und Vertrieb sollten \u00fcberpr\u00fcfen, ob <strong>Produktlisten und Unternehmensinformationen werden korrekt wiedergegeben.<\/strong> in der \u00f6ffentlichen Datenbank. Organisationen k\u00f6nnen auch die \u00dcberwachung k\u00fcnftiger Transparenzinitiativen in Betracht ziehen unter <strong>Operation Storchengeschwindigkeit<\/strong> um \u00fcber m\u00f6gliche politische Entwicklungen oder regulatorische Ma\u00dfnahmen informiert zu bleiben.<\/p>\n<p>Da sich Initiativen zur regulatorischen Transparenz st\u00e4ndig weiterentwickeln, wird es immer wichtiger, den \u00dcberblick \u00fcber globale regulatorische Aktualisierungen zu behalten. <a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> Unterst\u00fctzt Organisationen bei der \u00dcberwachung regulatorischer Entwicklungen und der Verwaltung der Einhaltung von Arbeitsabl\u00e4ufen \u00fcber mehrere Rechtsordnungen hinweg.<\/p>\n<p><a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> ist 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, <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. <a href=\"http:\/\/regask.com\/de\/\"><strong>Mehr erfahren <\/strong><\/a>oder<strong><a href=\"https:\/\/regask.com\/de\/demo-buchen\/\"> Jetzt Demo buchen.<\/a>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-509987719 > .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-1001554913\">\n\n\t<div id=\"col-1198051177\" 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-1023361936\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1023361936 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW99703309 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW99703309 BCX0\" data-ccp-parastyle=\"heading 3\">Wie lautet der Entwurf der FDA-Leitlinie zur dreij\u00e4hrigen Exklusivit\u00e4t klinischer Pr\u00fcfungen?<\/span><\/span><span class=\"EOP SCXW99703309 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1218414458\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1218414458 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">Der\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">FDA-Leitlinienentwurf vom 4. M\u00e4rz,\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW263241192 BCX0\">2026<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>\u00a0<\/strong>bietet Empfehlungen f\u00fcr Bewerber, die<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">dreij\u00e4hrige Exklusivit\u00e4t f\u00fcr klinische Pr\u00fcfungen<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0f\u00fcr\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">Zulassungsantr\u00e4ge f\u00fcr neue Arzneimittel (NDAs)<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">oder<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">NDA-Erg\u00e4nzungen<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>.<\/strong>\u00a0<\/span><span class=\"NormalTextRun SCXW263241192 BCX0\">Es erkl\u00e4rt die\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">Zulassungskriterien<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>\u00a0<\/strong>und umrei\u00dft die\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">Inhalt und Format<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0Dies wird bei Exklusivit\u00e4tsanfragen erwartet.<\/span><\/span><span class=\"EOP SCXW263241192 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-1198051177 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1098726226\" 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 SCXW114531365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW114531365 BCX0\" data-ccp-parastyle=\"heading 3\">Wer kann eine dreij\u00e4hrige Exklusivit\u00e4t f\u00fcr klinische Pr\u00fcfungen beantragen?<\/span><\/span><span class=\"EOP SCXW114531365 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1365266653\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1365266653 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">Bewerber\u00a0<\/span><span class=\"NormalTextRun SCXW124616724 BCX0\">Einreichen<\/span><span class=\"NormalTextRun SCXW124616724 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">Urspr\u00fcngliche NDAs oder NDA-Erg\u00e4nzungen, die durch neue klinische Studien unterst\u00fctzt werden<\/span><\/span><\/strong><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">\u00a0kann anfordern\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">dreij\u00e4hrige Exklusivit\u00e4t<\/span><\/span><\/strong><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\"><strong>,<\/strong> vorausgesetzt, sie erf\u00fcllen die von der FDA festgelegten gesetzlichen und regulatorischen Zulassungsvoraussetzungen.<\/span><\/span><span class=\"EOP SCXW124616724 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-1098726226 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-795638662\" 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 SCXW110399116 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">Wann ist die Frist f\u00fcr\u00a0<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">einreichen<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0Anmerkungen zum FDA-Leitlinienentwurf?<\/span><\/span><span class=\"EOP SCXW110399116 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1365762999\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1365762999 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">Interessengruppen k\u00f6nnten\u00a0<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">einreichen<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">\u00a0Feedback zum\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">Leitlinienentwurf<\/span><\/span><\/strong><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">bis<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">4. Mai 2026<\/span><\/span><\/strong><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\"><strong>,<\/strong> unter Verwendung der FDA\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">Online- oder schriftliche Einreichungskan\u00e4le<\/span><\/span><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">.<\/span><\/span><span class=\"EOP SCXW109329519 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-795638662 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-901782274\" 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 bei der Einhaltung der Kennzeichnungsvorschriften f\u00fcr GVO unterst\u00fctzen?<\/h4>\n\t<div id=\"gap-638428667\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-638428667 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/de\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW19024172 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0bietet\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">KI-gest\u00fctzte regulatorische Intelligenz und Workflow-Automatisierung<\/span><\/span><\/strong><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0das es Organisationen erm\u00f6glicht\u00a0<\/span><span class=\"NormalTextRun SCXW19024172 BCX0\">Monitor<\/span><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">Aktualisierungen der FDA-Leitlinien, regulatorische \u00c4nderungen und Einreichungsanforderungen<\/span><\/span><\/strong><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0auf globalen M\u00e4rkten. Dies hilft Regulierungs- und Compliance-Teams, informiert zu bleiben, die Auswirkungen regulatorischer Vorgaben zu bewerten und die Vorbereitung von Einreichungen zu optimieren.<\/span><\/span><span class=\"EOP SCXW19024172 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-901782274 > .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 einen Entwurf eines Leitfadens zur dreij\u00e4hrigen Exklusivit\u00e4t klinischer Pr\u00fcfungen f\u00fcr Arzneimittel. Der Leitfaden pr\u00e4zisiert die regulatorischen Anforderungen an Antragsteller, die Exklusivit\u00e4t f\u00fcr Zulassungsantr\u00e4ge (NDAs) und NDA-Erg\u00e4nzungen anstreben, insbesondere wenn diese Antr\u00e4ge durch neue klinische Pr\u00fcfungen unterst\u00fctzt werden. Der Entwurf soll Antragstellern helfen, die gesetzlichen und regulatorischen Voraussetzungen f\u00fcr die Erlangung einer dreij\u00e4hrigen Exklusivit\u00e4t zu verstehen.<\/p>","protected":false},"author":43,"featured_media":9621,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,39],"tags":[],"class_list":["post-9620","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-medical-devices-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 Issues Draft Guidance on Three-Year Exclusivity<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. Learn more today.\" \/>\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\/die-fda-veroffentlicht-einen-leitlinienentwurf-zur-dreijahrigen-exklusivitat-klinischer-prufungen-fur-ndas-und-nahrungserganzungsmittel\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Draft Guidance on Three-Year Clinical Investigation Exclusivity for NDAs and Supplements\" \/>\n<meta property=\"og:description\" content=\"Explore the FDA&#039;s draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. 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