{"id":9589,"date":"2026-03-03T22:23:32","date_gmt":"2026-03-03T14:23:32","guid":{"rendered":"https:\/\/regask.com\/?p=9589"},"modified":"2026-03-03T22:23:32","modified_gmt":"2026-03-03T14:23:32","slug":"die-fda-veroffentlicht-entwurfe-produktspezifischer-leitlinien-zur-unterstutzung-der-generikaentwicklung-und-der-anda-zulassungen","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-issues-draft-product-specific-guidances-to-support-generic-drug-development-and-anda-approvals\/","title":{"rendered":"Die FDA ver\u00f6ffentlicht Entw\u00fcrfe produktspezifischer Leitlinien zur Unterst\u00fctzung \u2026"},"content":{"rendered":"<p>An <strong>26. Februar 2026, <\/strong>Die<strong> Die US-amerikanische Lebensmittel- und Arzneimittelbeh\u00f6rde (FDA) hat eine Reihe von Entw\u00fcrfen produktspezifischer Leitlinien (PSGs) ver\u00f6ffentlicht.<\/strong> mit dem Ziel, die Entwicklung von Generika zu unterst\u00fctzen und zu optimieren <strong>Verk\u00fcrzter Zulassungsantrag f\u00fcr ein neues Arzneimittel (ANDA)<\/strong> Zulassungen f\u00fcr Arzneimittel. Die Aktualisierung betrifft Unternehmen und Teams, die an der Entwicklung, Einreichung oder Pr\u00fcfung von ANDAs beteiligt sind, insbesondere f\u00fcr beide <strong>Komplexe und nicht-komplexe Generika. <\/strong><\/p>\n<div class=\"row\"  id=\"row-579689456\">\n\n\t<div id=\"col-522833901\" 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-1912346653\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1912346653 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>Details zum Update<\/h2>\n\t<div id=\"gap-1353566015\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1353566015 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Die FDA hat neue und \u00fcberarbeitete Entw\u00fcrfe von PSGs ver\u00f6ffentlicht, die die regulatorischen Erwartungen an den Nachweis von <strong>therapeutische \u00c4quivalenz<\/strong> Die Leitlinien beziehen sich auf gelistete Arzneimittel. Sie umfassen 98 Produkte, darunter auch solche mit <strong>Derzeit sind keine Generika zugelassen.,<\/strong> und neue Leitlinien einf\u00fchren f\u00fcr <strong>Behandlungen der Opioidabh\u00e4ngigkeit <\/strong>Und<strong> Orale Einnahme von Semaglutid zur Reduktion des kardiovaskul\u00e4ren Risikos.\u00a0<\/strong><\/p>\n<p>Mehrere bestehende PSGs wurden \u00fcberarbeitet, wobei die Aktualisierungen Auswirkungen auf <strong>Formulierungen mit ver\u00e4nderter Wirkstofffreisetzung sowie transdermale und topische Systeme,<\/strong> was zu \u00c4nderungen der Studienerwartungen f\u00fchrt, wie zum Beispiel<strong> Studien zur Alkoholdosis-Entladung <\/strong>Und<strong> Sensibilisierungstestung.<\/strong> Dar\u00fcber hinaus aktualisierte die FDA ihre Online-Liste um folgende Eintr\u00e4ge: <strong>Die kommenden PSG-Spiele befinden sich in der Entwicklung.,<\/strong> zusammen mit voraussichtlichen Ver\u00f6ffentlichungsterminen zur Unterst\u00fctzung der Entwicklungsplanung.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-522833901 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-813035887\" 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-556928786\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-556928786 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Diese PSG-Entw\u00fcrfe bieten mehr <strong>regulatorische Klarheit<\/strong> zu Studiendesign und Datenanforderungen f\u00fcr die Entwicklung von Generika, Unterst\u00fctzung <strong>digitale Ausrichtung und Planungseffizienz<\/strong> f\u00fcr ANDA-Programme. Durch die Kl\u00e4rung der Erwartungen an komplexe und nicht-komplexe Produkte zielt das Update darauf ab, die Vorhersagbarkeit zu verbessern und gleichzeitig die... <strong>neutrale Auswirkungen und minimale zus\u00e4tzliche regulatorische Belastung<\/strong> f\u00fcr Branchenakteure.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-813035887 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1061225349\" 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-1153236921\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1153236921 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Dieses Update ist relevant f\u00fcr <strong>Zulassungsangelegenheiten, Qualit\u00e4tssicherung, Forschung und Entwicklung, <\/strong>Und<strong> Rechtsteams<\/strong> beteiligt an der Entwicklung von Generika und ANDA-Antr\u00e4gen, insbesondere solche, die an komplexen Formulierungen oder Produkten mit sich entwickelnden Studienanforderungen arbeiten.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1061225349 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-43857919\" 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-255175522\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-255175522 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Unternehmen sollten <strong>Bewertung aktueller und geplanter ANDA-Einreichungen<\/strong> gegen die neu ver\u00f6ffentlichten und \u00fcberarbeiteten PSGs, um etwaige L\u00fccken in Studienprotokollen oder Datenpaketen zu identifizieren. Sofern Entwicklungsprogramme betroffen sein k\u00f6nnten, k\u00f6nnen die Antragsteller dies tun. <strong>Telefonkonferenzen mit der FDA anfordern <\/strong>unter<strong> GDUFA III-Verpflichtungen.<\/strong> Es wird empfohlen, die PSG-Listungen der FDA fortlaufend zu \u00fcberwachen, um zuk\u00fcnftige Leitlinien, die f\u00fcr Produktportfolios relevant sind, vorherzusehen.<\/p>\n<p>Da sich die regulatorischen Anforderungen an Generika st\u00e4ndig weiterentwickeln, ist es f\u00fcr eine effiziente Entwicklungsplanung entscheidend, stets \u00fcber Entw\u00fcrfe und bevorstehende PSGs informiert zu sein. <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,<\/strong> <a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> bietet zeitnahe, vorausschauende und umsetzbare Erkenntnisse sowie eine durchg\u00e4ngige Automatisierung, die Teams dabei unterst\u00fctzt, Aktualisierungen der FDA-Leitlinien zu verfolgen, die Auswirkungen auf ANDA-Programme zu bewerten und die Compliance-Workflows in mehr als 160 L\u00e4ndern zu optimieren. <a href=\"http:\/\/regask.com\/de\/\"><strong>Mehr erfahren <\/strong><\/a>oder<a href=\"https:\/\/regask.com\/de\/demo-buchen\/\"><strong> Jetzt Demo buchen.\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-43857919 > .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-1952444673\">\n\n\t<div id=\"col-676495056\" 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-36892748\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-36892748 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW45210204 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45210204 BCX0\">Was\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed GrammarErrorHighlight SCXW45210204 BCX0\">Sind<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0FDA-produktspezifisch\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW45210204 BCX0\">Leitlinien<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0(PSGs)?<\/span><\/span><span class=\"EOP SCXW45210204 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-1144857339\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1144857339 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Die FDA PSGs sind Leitliniendokumente, die empfohlene Studiendesigns und Datenanforderungen f\u00fcr den Nachweis der therapeutischen \u00c4quivalenz in Zulassungsantr\u00e4gen f\u00fcr Generika darlegen.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-676495056 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1559504312\" 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 SCXW266917646 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266917646 BCX0\">Wie viele Produkte sind im Entwurf des PSG-Updates vom Februar 2026 enthalten?<\/span><\/span><span class=\"EOP SCXW266917646 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-1617613156\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1617613156 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">Der Entwurf der Aktualisierung der FDA umfasst\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">98 Produkte<\/span><\/span><span class=\"TextRun SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">, einschlie\u00dflich neuer und \u00fcberarbeiteter\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW195383774 BCX0\">Leitlinien<\/span><span class=\"NormalTextRun SCXW195383774 BCX0\">.<\/span><\/span><span class=\"EOP SCXW195383774 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-1559504312 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1000149734\" 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 SCXW234189171 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234189171 BCX0\">Welche Arten von Generika sind von diesem Update am st\u00e4rksten betroffen?<\/span><\/span><span class=\"EOP SCXW234189171 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-896312929\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-896312929 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>Das Update betrifft insbesondere <strong>komplexe Produkte, Formulierungen mit ver\u00e4nderter Wirkstofffreisetzung, transdermale und topische Systeme,<\/strong> sowie Produkte f\u00fcr <strong>Opioidkonsumst\u00f6rung und orales Semaglutid. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1000149734 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1877263506\" 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 SCXW39904085 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW39904085 BCX0\">Wie kann\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW39904085 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW39904085 BCX0\">\u00a0Wie k\u00f6nnen Teams FDA-PSG-Aktualisierungen verwalten?<\/span><\/span><span class=\"EOP SCXW39904085 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-508226773\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-508226773 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/de\/\"><strong>RegASK<\/strong><\/a> Unterst\u00fctzt Regulierungs- und Entwicklungsteams bei der Verfolgung von Entw\u00fcrfen und finalisierten PSGs, der Bewertung ihrer Auswirkungen auf laufende ANDA-Programme und der Koordinierung regulatorischer Arbeitsabl\u00e4ufe mithilfe KI-gest\u00fctzter Erkenntnisse, die von Experten unterst\u00fctzt werden.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1877263506 > .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 February 26, 2026, the U.S. Food and Drug Administration (FDA) published a batch of draft product-specific guidances (PSGs) aimed at supporting generic drug development and streamlining Abbreviated New Drug Application (ANDA) approvals for pharmaceuticals. The update affects companies and teams involved in developing, submitting, or reviewing ANDAs, particularly for both complex and non-complex generic&#8230;<\/p>","protected":false},"author":43,"featured_media":9590,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9589","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 v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Issues Draft Product-Specific Guidances Overview<\/title>\n<meta name=\"description\" content=\"Explore the FDA issues regarding product-specific guidances to support generic drug development and ANDA approvals in 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