{"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":"guia-de-traduccion-de-las-normas-bpl-de-la-fda-de-ee-uu","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/us-fda-glp-translation-guidance\/","title":{"rendered":"La FDA de EE. UU. publica un borrador de gu\u00eda sobre traducci\u00f3n para una buena \u2026"},"content":{"rendered":"<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">Este borrador de gu\u00eda de la FDA de EE. UU. tiene como objetivo ayudar a los patrocinadores y laboratorios no cl\u00ednicos involucrados en el desarrollo de medicamentos a garantizar que la traducci\u00f3n de un informe de estudio al ingl\u00e9s de un estudio realizado de conformidad con las regulaciones BPL sea clara, precisa, completa y siga procesos y procedimientos escritos.<\/div>\n<\/div>\n<div><\/div>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">La gu\u00eda est\u00e1 escrita en un formato de preguntas y respuestas para proporcionar respuestas en l\u00ednea con la recomendaci\u00f3n de la FDA sobre el tema.<\/div>\n<\/div>\n<div><\/div>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">Los comentarios electr\u00f3nicos o escritos sobre el borrador de la gu\u00eda deben enviarse antes del 20 de febrero de 2024.<\/div>\n<\/div>\n<\/div>\n<\/div>\n\t<div id=\"gap-1768940811\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1768940811 {\n  padding-top: 40px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-1028138368\">\n\n\t<div id=\"col-759215824\" 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>Leer m\u00e1s<\/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\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/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This US FDA draft guidance is aimed at assisting sponsors and nonclinical laboratories involved in the development of drugs to ensure that translation of a study report into English from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 v27.6 (Yoast SEO v27.7) - 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. Stay compliant with RegASK.\" \/>\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\/es\/guia-de-traduccion-de-las-normas-bpl-de-la-fda-de-ee-uu\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Releases Draft Guidance on Translation for Good Laboratory Practice Study Reports\" \/>\n<meta property=\"og:description\" content=\"The US FDA releases draft guidance on translating Good Laboratory Practice study reports. Stay compliant with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/guia-de-traduccion-de-las-normas-bpl-de-la-fda-de-ee-uu\/\" \/>\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 minuto\" \/>\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\":\"es\"},{\"@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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