{"id":9626,"date":"2026-03-11T15:04:43","date_gmt":"2026-03-11T07:04:43","guid":{"rendered":"https:\/\/regask.com\/?p=9626"},"modified":"2026-03-11T15:04:43","modified_gmt":"2026-03-11T07:04:43","slug":"la-fda-publie-des-lignes-directrices-finales-sur-les-etudes-non-interventionnelles-utilisant-des-donnees-en-vie-reelle-pour-la-securite-des-medicaments-et-des-produits-biologiques","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/","title":{"rendered":"La FDA publie ses recommandations finales concernant les \u00e9tudes non interventionnelles\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">Sur\u00a0<\/span><b><span data-contrast=\"auto\">4 mars 2026<\/span><\/b><span data-contrast=\"auto\">, le\u00a0<\/span><b><span data-contrast=\"auto\">Administration am\u00e9ricaine des aliments et des m\u00e9dicaments (FDA)<\/span><\/b><span data-contrast=\"auto\">\u00a0\u00e9mis\u00a0<\/span><b><span data-contrast=\"auto\">orientations finales<\/span><\/b><span data-contrast=\"auto\">\u00a0d\u00e9crivant le\u00a0<\/span><b><span data-contrast=\"auto\">Principes g\u00e9n\u00e9raux pour la planification, la conception, l&#039;analyse et la communication des \u00e9tudes non interventionnelles utilisant des donn\u00e9es en vie r\u00e9elle (RWD)<\/span><\/b><span data-contrast=\"auto\">\u00a0pour \u00e9valuer la s\u00e9curit\u00e9 des m\u00e9dicaments. Ces lignes directrices s&#039;appliquent \u00e0\u00a0<\/span><b><span data-contrast=\"auto\">m\u00e9dicaments, vaccins et produits biologiques<\/span><\/b><span data-contrast=\"auto\">\u00a0et \u00e9tablit des attentes r\u00e9glementaires pour\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9tudes de s\u00e9curit\u00e9 post-commercialisation<\/span><\/b><span data-contrast=\"auto\">\u00a0men\u00e9e par des promoteurs pharmaceutiques et de produits biologiques.<\/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\">Ce document normalise la mani\u00e8re dont les \u00e9tudes non interventionnelles doivent \u00eatre men\u00e9es lorsqu&#039;elles sont utilis\u00e9es\u00a0<\/span><b><span data-contrast=\"auto\">sources de donn\u00e9es r\u00e9elles telles que les dossiers m\u00e9dicaux \u00e9lectroniques et les demandes d&#039;indemnisation<\/span><\/b><span data-contrast=\"auto\">, apportant des pr\u00e9cisions sur la conception des \u00e9tudes, la m\u00e9thodologie et les pratiques de rapport. Il remplace les versions pr\u00e9liminaires pr\u00e9c\u00e9dentes des lignes directrices et\u00a0<\/span><b><span data-contrast=\"auto\">retire les recommandations de la FDA de mai 2013 concernant les \u00e9tudes pharmaco\u00e9pid\u00e9miologiques de s\u00e9curit\u00e9 utilisant des ensembles de donn\u00e9es de sant\u00e9 \u00e9lectroniques<\/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<div class=\"row\"  id=\"row-44204233\">\n\n\t<div id=\"col-1330575877\" 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-815579243\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-815579243 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>D\u00e9tails de la mise \u00e0 jour<\/h2>\n\t<div id=\"gap-2085615277\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2085615277 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les lignes directrices finales d\u00e9finissent\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9tudes non interventionnelles<\/span><\/b><span data-contrast=\"auto\">\u00a0Ces approches de recherche consistent \u00e0 observer les r\u00e9sultats sans imposer de traitements ou d&#039;interventions sp\u00e9cifiques. Ces \u00e9tudes s&#039;appuient sur des donn\u00e9es r\u00e9elles recueillies lors de la prestation de soins de sant\u00e9 courants.<\/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\">La FDA recommande aux promoteurs de commencer par\u00a0<\/span><b><span data-contrast=\"auto\">formuler clairement les questions de recherche<\/span><\/b><span data-contrast=\"auto\">\u00a0et d\u2019identifier les sources de donn\u00e9es r\u00e9elles appropri\u00e9es pouvant \u00e9tayer des \u00e9valuations de s\u00e9curit\u00e9 fiables. Le guide souligne \u00e9galement la n\u00e9cessit\u00e9 de\u00a0<\/span><b><span data-contrast=\"auto\">d\u00e9finir pr\u00e9cis\u00e9ment les variables et les crit\u00e8res d&#039;\u00e9valuation de l&#039;\u00e9tude<\/span><\/b><span data-contrast=\"auto\">, en veillant \u00e0 ce que les ensembles de donn\u00e9es et les approches analytiques soient adapt\u00e9s \u00e0 l&#039;\u00e9valuation de s\u00e9curit\u00e9 pr\u00e9vue.<\/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\">En outre, le document souligne l&#039;importance de\u00a0<\/span><b><span data-contrast=\"auto\">corriger les biais et les facteurs de confusion<\/span><\/b><span data-contrast=\"auto\">\u00a0Lors de la conception et de l&#039;analyse de l&#039;\u00e9tude, les promoteurs sont tenus d&#039;int\u00e9grer des m\u00e9thodes permettant d&#039;identifier, d&#039;\u00e9valuer et d&#039;att\u00e9nuer les sources potentielles de biais susceptibles d&#039;affecter les conclusions relatives \u00e0 la s\u00e9curit\u00e9.<\/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\">La FDA pr\u00e9cise en outre ses attentes concernant\u00a0<\/span><b><span data-contrast=\"auto\">documentation d&#039;\u00e9tude transparente et rapports complets<\/span><\/b><span data-contrast=\"auto\">, y compris des descriptions d\u00e9taill\u00e9es des m\u00e9thodologies, des sources de donn\u00e9es et des approches analytiques utilis\u00e9es dans l&#039;\u00e9tude.<\/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-1330575877 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1384475283\" 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>Date d&#039;entr\u00e9e en vigueur<\/h2>\n\t<div id=\"gap-428887548\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-428887548 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">Le\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">Recommandations finales de la FDA concernant les \u00e9tudes non interventionnelles utilisant des donn\u00e9es en vie r\u00e9elle<\/span><\/span><\/strong><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">\u00a0devenu\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">efficace sur <strong>4 mars 2026<\/strong><\/span><\/span><strong><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">.<\/span><\/span><span class=\"EOP SCXW15748117 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-1384475283 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-795604306\" 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>Pourquoi c&#039;est important<\/h2>\n\t<div id=\"gap-1793745407\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1793745407 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">Cette mise \u00e0 jour fournit<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">Clarification r\u00e9glementaire concernant l&#039;utilisation des donn\u00e9es en vie r\u00e9elle dans la surveillance de la s\u00e9curit\u00e9 apr\u00e8s la mise sur le march\u00e9<\/span><\/span><\/strong><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\"><strong>.<\/strong> En standardisant la conception des \u00e9tudes, la gestion des biais et les pratiques de publication, ces lignes directrices favorisent davantage d&#039;\u00e9tudes.\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">des \u00e9valuations de s\u00e9curit\u00e9 coh\u00e9rentes, fiables et transparentes<\/span><\/span><\/strong><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">\u00a0tout en permettant une utilisation efficace des sources de donn\u00e9es de sant\u00e9 existantes.<\/span><\/span><span class=\"EOP SCXW234709501 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-795604306 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-472909835\" 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>\u00c0 qui cela s&#039;adresse-t-il ?<\/h2>\n\t<div id=\"gap-472832366\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-472832366 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">Ces recommandations concernent les \u00e9quipes impliqu\u00e9es dans\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">surveillance post-commercialisation et \u00e9valuation de la s\u00e9curit\u00e9<\/span><\/span><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">, <\/span><\/span><\/strong><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">y compris<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">Affaires r\u00e9glementaires, assurance qualit\u00e9, s\u00e9curit\u00e9 des patients, affaires juridiques et conformit\u00e9, commerce ou marketing, et fonctions de recherche et d\u00e9veloppement<\/span><\/span><\/strong><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 BCX0\">\u00a0au sein des organisations pharmaceutiques et biologiques.<\/span><\/span><span class=\"EOP SCXW75709743 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-472909835 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-698630546\" 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>Prochaines \u00e9tapes<\/h2>\n\t<div id=\"gap-158047791\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-158047791 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">Les organisations menant\u00a0<\/span><b><span data-contrast=\"auto\">\u00e9tudes de s\u00e9curit\u00e9 non interventionnelles utilisant des donn\u00e9es en vie r\u00e9elle<\/span><\/b><span data-contrast=\"auto\">\u00a0Il convient de revoir les protocoles et m\u00e9thodologies d&#039;\u00e9tude actuels afin de garantir leur conformit\u00e9 avec les nouvelles exigences de la FDA. Les parties prenantes doivent \u00e9galement \u00e9valuer les pratiques de documentation et les processus de rapportage au sein des services concern\u00e9s afin de confirmer que les plans d&#039;\u00e9tude, les m\u00e9thodes de s\u00e9lection des donn\u00e9es et les approches analytiques r\u00e9pondent aux nouvelles normes.<\/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\">\u00c0 mesure que les organismes de r\u00e9glementation formalisent de plus en plus les attentes concernant les donn\u00e9es du monde r\u00e9el et la surveillance de la s\u00e9curit\u00e9 apr\u00e8s la mise sur le march\u00e9, les organisations peuvent tirer profit d&#039;outils qui les aident \u00e0 suivre l&#039;\u00e9volution des directives r\u00e9glementaires et \u00e0 mettre en \u0153uvre la conformit\u00e9 sur les march\u00e9s mondiaux.<\/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\/fr\/\"><strong>RegASK<\/strong><\/a>\u00a0est une plateforme de pointe d&#039;intelligence r\u00e9glementaire et d&#039;orchestration des flux de travail bas\u00e9e sur l&#039;IA agentielle, qui permet aux organisations mondiales des secteurs hautement r\u00e9glement\u00e9s, notamment les produits de consommation et les sciences de la vie, de naviguer de mani\u00e8re proactive dans des environnements r\u00e9glementaires complexes.<strong> En combinant une IA agentique avanc\u00e9e avec des experts impliqu\u00e9s,\u00a0<a href=\"http:\/\/regask.com\/fr\/\">RegASK<\/a><\/strong> Elle fournit en temps opportun des informations pr\u00e9dictives exploitables et une automatisation de bout en bout, rationalisant les processus de conformit\u00e9, att\u00e9nuant les risques et acc\u00e9l\u00e9rant l&#039;acc\u00e8s au march\u00e9 dans plus de 160 pays. <strong><a href=\"http:\/\/regask.com\/fr\/\">En savoir plus<\/a> <\/strong>ou<a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\"><strong> r\u00e9servez une d\u00e9mo maintenant.<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-698630546 > .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-1044274497\">\n\n\t<div id=\"col-582379272\" 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>FAQ<\/h3>\n\t<div id=\"gap-972574842\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-972574842 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW22959475 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW22959475 BCX0\">Quelles sont les recommandations de la FDA pour 2026 concernant les \u00e9tudes non interventionnelles utilisant des donn\u00e9es en vie r\u00e9elle\u00a0?<\/span><\/span><span class=\"EOP SCXW22959475 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-797356563\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-797356563 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW182041197 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182041197 BCX0\">Les directives d\u00e9crivent\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW182041197 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182041197 BCX0\">Principes g\u00e9n\u00e9raux pour la planification, la conception, l&#039;analyse et la communication des r\u00e9sultats d&#039;\u00e9tudes non interventionnelles utilisant des donn\u00e9es en situation r\u00e9elle<\/span><\/span><\/strong><span class=\"TextRun SCXW182041197 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW182041197 BCX0\">\u00a0\u00c9valuer l\u2019innocuit\u00e9 des m\u00e9dicaments, des vaccins et des produits biologiques apr\u00e8s leur mise sur le march\u00e9.<\/span><\/span><span class=\"EOP SCXW182041197 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-582379272 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1898938273\" 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 SCXW169711913 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW169711913 BCX0\">Quels types de donn\u00e9es sont consid\u00e9r\u00e9s comme des donn\u00e9es du monde r\u00e9el dans ce guide\u00a0?<\/span><\/span><span class=\"EOP SCXW169711913 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-367196387\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-367196387 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW97422678 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97422678 BCX0\">La FDA\u00a0<\/span><span class=\"NormalTextRun SCXW97422678 BCX0\">identifie<\/span><span class=\"NormalTextRun SCXW97422678 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW97422678 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97422678 BCX0\">sources de donn\u00e9es telles que les dossiers m\u00e9dicaux \u00e9lectroniques et les demandes d&#039;indemnisation<\/span><\/span><\/strong><span class=\"TextRun SCXW97422678 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW97422678 BCX0\">\u00a0\u00e0 titre d\u2019exemples de donn\u00e9es r\u00e9elles pouvant \u00eatre utilis\u00e9es dans des \u00e9tudes de s\u00e9curit\u00e9 non interventionnelles.<\/span><\/span><span class=\"EOP SCXW97422678 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-1898938273 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2047301123\" 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 SCXW258517632 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW258517632 BCX0\">Ce guide remplace-t-il\u00a0<\/span><span class=\"NormalTextRun SCXW258517632 BCX0\">pr\u00e9c\u00e9dent<\/span><span class=\"NormalTextRun SCXW258517632 BCX0\">\u00a0Recommandations de la FDA ?<\/span><\/span><span class=\"EOP SCXW258517632 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-1507451153\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1507451153 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW185775808 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185775808 BCX0\">Oui. Les directives finales<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW185775808 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185775808 BCX0\">retire les recommandations de la FDA de mai 2013 concernant les \u00e9tudes pharmaco\u00e9pid\u00e9miologiques de s\u00e9curit\u00e9 utilisant des ensembles de donn\u00e9es de sant\u00e9 \u00e9lectroniques<\/span><\/span><\/strong><span class=\"TextRun SCXW185775808 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW185775808 BCX0\">\u00a0et remplace les recommandations pr\u00e9liminaires.<\/span><\/span><span class=\"EOP SCXW185775808 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-2047301123 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-601543075\" 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>Comment RegASK peut-il aider les entreprises \u00e0 suivre les mises \u00e0 jour r\u00e9glementaires relatives aux pr\u00e9parations pour nourrissons\u00a0?<\/h4>\n\t<div id=\"gap-987380998\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-987380998 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW177493038 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/fr\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW177493038 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW177493038 BCX0\">\u00a0aide les organisations\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW177493038 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW177493038 BCX0\">Suivre l&#039;\u00e9volution des directives r\u00e9glementaires, interpr\u00e9ter les exigences de conformit\u00e9 et rationaliser les flux de travail r\u00e9glementaires.<\/span><\/span><\/strong><span class=\"TextRun SCXW177493038 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW177493038 BCX0\"><strong>,<\/strong> permettre aux \u00e9quipes charg\u00e9es des affaires r\u00e9glementaires, de la s\u00e9curit\u00e9 et de la conformit\u00e9 de r\u00e9agir plus efficacement aux mises \u00e0 jour telles que les nouvelles directives de la FDA sur les \u00e9tudes de donn\u00e9es en situation r\u00e9elle.<\/span><\/span><span class=\"EOP SCXW177493038 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-601543075 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Le 4 mars 2026, la Food and Drug Administration (FDA) am\u00e9ricaine a publi\u00e9 des lignes directrices finales \u00e9non\u00e7ant les principes g\u00e9n\u00e9raux de planification, de conception, d&#039;analyse et de publication des \u00e9tudes non interventionnelles utilisant des donn\u00e9es en vie r\u00e9elle (DVR) pour \u00e9valuer la s\u00e9curit\u00e9 des m\u00e9dicaments. Ces lignes directrices s&#039;appliquent aux m\u00e9dicaments, aux vaccins et aux produits biologiques et d\u00e9finissent les exigences r\u00e9glementaires relatives aux \u00e9tudes de s\u00e9curit\u00e9 post-commercialisation men\u00e9es par les promoteurs pharmaceutiques et de produits biologiques. Ce document normalise la mani\u00e8re dont les \u00e9tudes non interventionnelles doivent \u00eatre men\u00e9es\u2026<\/p>","protected":false},"author":43,"featured_media":9627,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9626","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 v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Issues Final Guidance on Non-Interventional Studies<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s final guidance on non-interventional studies using real-world data for drug and biologic safety assessments.\" \/>\n<meta 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content=\"https:\/\/regask.com\/fr\/la-fda-publie-des-lignes-directrices-finales-sur-les-etudes-non-interventionnelles-utilisant-des-donnees-en-vie-reelle-pour-la-securite-des-medicaments-et-des-produits-biologiques\/\" \/>\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=\"2026-03-11T07:04:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-final-guidance-non-interventional-studies-real-world-data-drug-biologic-safety.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Reva Ananda\" \/>\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=\"Reva Ananda\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"FDA Issues Final Guidance on Non-Interventional 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