{"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-565991873\">\n\n\t<div id=\"col-2126418143\" 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-215316227\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-215316227 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-44586618\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-44586618 {\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-2126418143 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1445999215\" 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-1467661241\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1467661241 {\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-1445999215 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2048504420\" 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-99605800\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-99605800 {\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-2048504420 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-695877553\" 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-413138440\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-413138440 {\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-695877553 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1277492563\" 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-1070503069\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1070503069 {\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-1277492563 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-197951016\" 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-1361911129\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1361911129 {\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-197951016 > .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-1329038360\">\n\n\t<div id=\"col-1446181647\" 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-1114406762\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1114406762 {\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-37014669\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-37014669 {\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-1446181647 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-221092194\" 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-1914887699\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1914887699 {\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-221092194 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1645262180\" 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-795208131\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-795208131 {\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-1645262180 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-671714881\" 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-451795694\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-451795694 {\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-671714881 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On\u00a0March 4, 2026, the\u00a0U.S. Food and Drug Administration (FDA)\u00a0published a\u00a0draft guidance document\u00a0addressing\u00a0three-year clinical investigation exclusivity\u00a0for drug products. The guidance clarifies regulatory expectations for applicants seeking exclusivity for\u00a0new drug applications (NDAs)\u00a0and\u00a0NDA supplements, particularly when new clinical investigations support these submissions.\u00a0 The draft guidance is intended to help applicants understand the\u00a0statutory and regulatory eligibility criteria\u00a0required\u00a0to obtain\u00a03-year exclusivity&#8230;.<\/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 v27.6 (Yoast SEO v27.6) - 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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