{"id":4650,"date":"2023-12-05T10:30:38","date_gmt":"2023-12-05T02:30:38","guid":{"rendered":"https:\/\/regask.com\/?p=4650"},"modified":"2024-10-24T01:46:00","modified_gmt":"2024-10-23T17:46:00","slug":"us-fda-glp-ubersetzungsleitfaden","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/us-fda-glp-translation-guidance\/","title":{"rendered":"US-amerikanische FDA ver\u00f6ffentlicht Leitlinienentwurf zur \u00dcbersetzung f\u00fcr gute Zwecke \u2026"},"content":{"rendered":"<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">Dieser Leitlinienentwurf der US-amerikanischen FDA soll Sponsoren und nichtklinische Labore, die an der Entwicklung von Arzneimitteln beteiligt sind, dabei unterst\u00fctzen, sicherzustellen, dass die \u00dcbersetzung eines Studienberichts ins Englische aus einer unter Einhaltung der GLP-Vorschriften durchgef\u00fchrten Studie klar, genau und vollst\u00e4ndig ist und den schriftlichen Prozessen und Verfahren entspricht.<\/div>\n<\/div>\n<div><\/div>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">Die Anleitung ist im Frage-und-Antwort-Format verfasst, um Antworten im Einklang mit der Empfehlung der FDA zu diesem Thema zu liefern.<\/div>\n<\/div>\n<div><\/div>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">Elektronische oder schriftliche Kommentare zum Leitlinienentwurf sollten bis zum 20. Februar 2024 eingereicht werden<\/div>\n<\/div>\n<\/div>\n<\/div>\n\t<div id=\"gap-657333073\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-657333073 {\n  padding-top: 40px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-509699639\">\n\n\t<div id=\"col-299269450\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/translation-good-laboratory-practice-study-reports-questions-and-answers\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>This US FDA draft guidance is aimed at assisting sponsors and nonclinical laboratories involved in the development of drugs to ensure that translation of a study report into English from a study conducted in compliance with GLP regulations, is clear, accurate, complete, and follow written processes and procedure. The guidance is written in a Question-and-Answer&#8230;<\/p>","protected":false},"author":39,"featured_media":4641,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[40,219,221],"class_list":["post-4650","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-latest-insights","tag-drug-development","tag-good-laboratory-practice"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US FDA: GLP Translation Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The US FDA releases draft guidance on translating Good Laboratory Practice study reports. 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Stay compliant with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/us-fda-glp-ubersetzungsleitfaden\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-12-05T02:30:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-23T17:46:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2023\/12\/US-FDA-Released-Draft-Guidance-on-Good-Laboratory-Practice-Study-Reports-Translation.png\" \/>\n\t<meta property=\"og:image:width\" content=\"330\" \/>\n\t<meta property=\"og:image:height\" content=\"300\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\u00a0Minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-glp-translation-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-glp-translation-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA Releases Draft Guidance on Translation for Good &hellip;\",\"datePublished\":\"2023-12-05T02:30:38+00:00\",\"dateModified\":\"2024-10-23T17:46:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-glp-translation-guidance\\\/\"},\"wordCount\":142,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-glp-translation-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/12\\\/US-FDA-Released-Draft-Guidance-on-Good-Laboratory-Practice-Study-Reports-Translation.png\",\"keywords\":[\"Latest Insights\",\"Drug Development\",\"Good Laboratory Practice\"],\"articleSection\":[\"Pharma and Biotech\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-glp-translation-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/us-fda-glp-translation-guidance\\\/\",\"name\":\"US FDA: GLP Translation Guidance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-glp-translation-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/us-fda-glp-translation-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2023\\\/12\\\/US-FDA-Released-Draft-Guidance-on-Good-Laboratory-Practice-Study-Reports-Translation.png\",\"datePublished\":\"2023-12-05T02:30:38+00:00\",\"dateModified\":\"2024-10-23T17:46:00+00:00\",\"description\":\"The US FDA releases draft guidance on translating Good Laboratory Practice study reports. 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