{"id":7054,"date":"2020-03-05T12:14:03","date_gmt":"2020-03-05T12:14:03","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7054"},"modified":"2021-09-30T18:47:12","modified_gmt":"2021-09-30T18:47:12","slug":"how-can-you-improve-your-chances-of-getting-fda-approval","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/fr\/how-can-you-improve-your-chances-of-getting-fda-approval\/","title":{"rendered":"Comment pouvez-vous am\u00e9liorer vos chances d'obtenir l'approbation de la FDA ?"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table des mati\u00e8res<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f1ad09dd9dc\" aria-label=\"Table des mati\u00e8res\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f1ad09dd9dc\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/how-can-you-improve-your-chances-of-getting-fda-approval\/#1_Organise_your_paperwork\" title=\"1. Organisez vos papiers\">1. Organisez vos papiers<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/how-can-you-improve-your-chances-of-getting-fda-approval\/#2_Present_measurable_evidence\" title=\"2. Pr\u00e9senter des preuves mesurables\">2. Pr\u00e9senter des preuves mesurables<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/how-can-you-improve-your-chances-of-getting-fda-approval\/#3_Keep_a_thorough_record\" title=\"3. Tenir un registre complet\">3. Tenir un registre complet<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/how-can-you-improve-your-chances-of-getting-fda-approval\/#Final_considerations\" title=\"Consid\u00e9rations finales\">Consid\u00e9rations finales<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Dr. Harneet Arora, scientifique clinique ind\u00e9pendante et <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\" target=\"_blank\" rel=\"noopener noreferrer\">Expert en r\u00e9glementation de la FDA<\/a>Elle donne des conseils sur la mani\u00e8re d'obtenir l'approbation de la FDA pour un nouveau m\u00e9dicament et sur la fa\u00e7on d'\u00e9viter les erreurs courantes.\u00a0<\/em><\/p>\n<p>The commercialisation of a new drug in the United States follows a rigid path. Each step along the process, from <a href=\"https:\/\/www.kolabtree.com\/blog\/fr\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">recherche<\/a> and development to labelling and final release on the market, is strictly monitored by the Food and Drug Administration (FDA). However, applying for FDA approval for a new drug can be a real minefield.<\/p>\n<blockquote><p>Selon une \u00e9tude r\u00e9cente du Massachusetts Institute of Technology, seuls 14% environ de tous les m\u00e9dicaments faisant l'objet d'essais cliniques sont approuv\u00e9s par la FDA, l'agence f\u00e9d\u00e9rale am\u00e9ricaine charg\u00e9e de prot\u00e9ger et de promouvoir la sant\u00e9 publique. Cela signifie que pour 86% de tous les nouveaux m\u00e9dicaments propos\u00e9s, quelque chose ne va pas tout au long du processus de commercialisation, ce qui entra\u00eene une perte de temps, d'\u00e9nergie et de capitaux.<\/p><\/blockquote>\n<p>Quelles sont donc les erreurs \u00e9vitables les plus courantes lors d'une demande d'autorisation aupr\u00e8s de la FDA et que peuvent faire les demandeurs pour \u00e9viter qu'elles ne se produisent ? <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/harneet-arora-pt\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Dr. Harneet Arora<\/a>, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\">expert ind\u00e9pendant en soumissions \u00e0 la FDA<\/a> sur Kolabtree, partage ses meilleurs conseils.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Organise_your_paperwork\"><\/span>1. Organisez vos papiers<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>La premi\u00e8re erreur - et la plus facile \u00e0 \u00e9viter - est de pr\u00e9senter une demande incompl\u00e8te. V\u00e9rifiez le <a href=\"https:\/\/www.fda.gov\/drugs\/types-applications\/new-drug-application-nda\">Site web de la FDA<\/a> pour vous assurer que vous soumettez tous les formulaires requis et qu'ils sont bien remplis. Soyez particuli\u00e8rement attentif lorsque vous remplissez le formulaire 1572, l'un des documents cl\u00e9s de votre soumission de drogue nouvelle de recherche (DNR).<\/p>\n<p>Le formulaire 1572 permet de s'assurer que les demandeurs n'ont pas de parti pris ou de conflit d'int\u00e9r\u00eats, qu'ils acceptent de suivre le Code of Federal Regulations de la FDA pour les essais cliniques et qu'ils ont l'exp\u00e9rience n\u00e9cessaire pour mener l'\u00e9tude d'une mani\u00e8re \u00e9thique et scientifiquement rigoureuse. En \u00e9vitant les erreurs dans ce formulaire, vous \u00e9viterez un blocage ult\u00e9rieur.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Present_measurable_evidence\"><\/span>2. Pr\u00e9senter des preuves mesurables<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Une fois que toutes les phases d'un essai clinique ont \u00e9t\u00e9 men\u00e9es \u00e0 bien, la FDA examine les r\u00e9sultats et organise une discussion ouverte - souvent virtuelle - au cours de laquelle les entreprises pharmaceutiques pr\u00e9sentent les preuves que le m\u00e9dicament qu'elles proposent est efficace et offre des avantages significatifs par rapport aux m\u00e9dicaments existants pour la m\u00eame maladie. Ici, l'objectif n'est pas d'\u00e9tablir si le nouveau m\u00e9dicament sera s\u00fbr - cela a d\u00e9j\u00e0 \u00e9t\u00e9 d\u00e9termin\u00e9 par des \u00e9tudes in vitro et in vivo - mais de prouver qu'il am\u00e9liorera sensiblement la vie des patients.<\/p>\n<p>D'apr\u00e8s mon exp\u00e9rience, la plupart des rejets surviennent \u00e0 ce stade en raison d'un manque de donn\u00e9es claires sur l'efficacit\u00e9 du m\u00e9dicament et sur la fa\u00e7on dont il est meilleur que les traitements d\u00e9j\u00e0 commercialis\u00e9s. Il est donc important de pr\u00e9senter des param\u00e8tres mesurables sur l'efficacit\u00e9 du m\u00e9dicament.<\/p>\n<blockquote><p>Par exemple, il ne suffit pas d'indiquer que les sympt\u00f4mes des patients se sont am\u00e9lior\u00e9s au 2%, il est n\u00e9cessaire de pr\u00e9ciser la nature de cette am\u00e9lioration.<\/p><\/blockquote>\n<p>Il est \u00e9galement important de fournir un cadre de r\u00e9f\u00e9rence pour \u00e9valuer cette am\u00e9lioration. Il peut s'agir d'une comparaison entre un groupe de patients prenant le nouveau m\u00e9dicament et un groupe t\u00e9moin prenant un placebo, ou un groupe prenant un m\u00e9dicament d\u00e9j\u00e0 sur le march\u00e9.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Keep_a_thorough_record\"><\/span>3. Tenir un registre complet<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Il est essentiel de documenter correctement chaque \u00e9tape du d\u00e9veloppement et des essais d'un nouveau m\u00e9dicament, depuis les donn\u00e9es pr\u00e9cliniques pr\u00e9cises sur les \u00e9tudes in vitro et sur les animaux, jusqu'\u00e0 la mani\u00e8re dont la dose initiale et maximale recommand\u00e9e a \u00e9t\u00e9 \u00e9tablie. Les demandeurs doivent \u00e9galement prouver que le m\u00e9dicament a \u00e9t\u00e9 test\u00e9 sur un nombre suffisant de sujets et doivent documenter soigneusement la fa\u00e7on dont ils ont r\u00e9agi au traitement. En particulier, les demandeurs doivent signaler tout effet secondaire ind\u00e9sirable que les sujets ont subi. Si certains des sujets d\u00e9cident d'abandonner l'essai, le demandeur doit en expliquer la raison.<\/p>\n<blockquote><p>Il est \u00e9galement n\u00e9cessaire de prouver que les avantages du nouveau m\u00e9dicament l'emportent sur ses effets secondaires et que ceux-ci sont moins graves que ceux des m\u00e9dicaments d\u00e9j\u00e0 commercialis\u00e9s pour la m\u00eame maladie. Par exemple, un m\u00e9dicament destin\u00e9 \u00e0 traiter une maladie en phase terminale qui provoque des vomissements et des migraines pourrait tout de m\u00eame \u00eatre approuv\u00e9 s'il augmente consid\u00e9rablement l'esp\u00e9rance de vie des patients. Si les m\u00eames effets secondaires \u00e9taient signal\u00e9s pour un m\u00e9dicament destin\u00e9 \u00e0 traiter l'hypertension, l'autorisation serait tr\u00e8s probablement refus\u00e9e, car il existe d\u00e9j\u00e0 sur le march\u00e9 des traitements pour cette maladie dont les effets secondaires sont moindres.<\/p><\/blockquote>\n<p>Dans tous les cas, les demandeurs doivent pr\u00e9senter leurs strat\u00e9gies d'\u00e9valuation et d'att\u00e9nuation des risques (REMS), dans lesquelles ils doivent expliquer en d\u00e9tail les mesures qu'ils pr\u00e9voient de prendre pour minimiser les \u00e9ventuels effets secondaires. Lors de la r\u00e9daction de cette section, veillez \u00e0 \u00eatre aussi pr\u00e9cis que possible sur ce que les patients doivent faire pour \u00e9viter les effets secondaires, par exemple en d\u00e9crivant s'ils doivent utiliser un moyen de contraception pendant le traitement, et si oui, quel type.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Final_considerations\"><\/span>Consid\u00e9rations finales<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>Pour que le nouveau m\u00e9dicament soit approuv\u00e9, au moins 80% des sujets de l'essai doivent montrer des signes d'am\u00e9lioration.<\/strong> Pour s'assurer que ces preuves sont pr\u00e9sent\u00e9es correctement et que le groupe \u00e9chantillon est suffisamment grand pour fournir des donn\u00e9es significatives, les demandeurs peuvent avoir besoin de l'aide d'un statisticien expert. \u00c0 ce stade, les entreprises qui ne disposent pas d'un statisticien en interne devraient envisager de collaborer avec un ind\u00e9pendant, qui peut les aider \u00e0 s\u00e9lectionner le groupe \u00e9chantillon et \u00e0 collecter et analyser les donn\u00e9es cliniques.<\/p>\n<p>Enfin, il est important de garder \u00e0 l'esprit qu'\u00e0 tout moment, la FDA peut auditer l'installation o\u00f9 le m\u00e9dicament est d\u00e9velopp\u00e9 et test\u00e9, pour s'assurer qu'elle est conforme aux directives de bonnes pratiques cliniques (BPC). Par exemple, lors d'un audit, la FDA peut v\u00e9rifier que tout le personnel poss\u00e8de les qualifications n\u00e9cessaires pour accomplir ses t\u00e2ches en toute s\u00e9curit\u00e9.<\/p>\n<p>Demander l'approbation de la FDA peut \u00eatre \u00e9prouvant, mais consulter des experts qui ont une connaissance d\u00e9taill\u00e9e des proc\u00e9dures de la FDA peut simplifier le processus. Certaines entreprises pharmaceutiques peuvent disposer d'un service interne de r\u00e9glementation \u00e0 cette fin, mais les petites entreprises peuvent ne pas avoir la capacit\u00e9 et le budget n\u00e9cessaires pour un tel investissement. Dans ce cas, l'embauche d'un expert ind\u00e9pendant peut \u00eatre la solution.<\/p>\n<p><strong>Kolabtree vous aide \u00e0 engager des experts de la FDA et \u00e0 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">r\u00e9dacteurs r\u00e9glementaires ind\u00e9pendants<\/a>sur demande. <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA#create-project\">Publiez votre projet et obtenez des devis gratuitement<\/a>.\u00a0<\/strong><\/p>\n<p><strong>Experts connexes :\u00a0<\/strong><\/p>\n<p><strong><a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Bioinformatics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Pigiste en bioinformatique<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Plant-Genetics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">G\u00e9n\u00e9tique v\u00e9g\u00e9tale<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Developmental-Biology?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Biologie du d\u00e9veloppement<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Gene-Therapy?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Th\u00e9rapie g\u00e9nique<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Stem-Cells?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Cellules souches <\/a>|<\/strong><br \/>\n<strong><a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/DNA-Sequencing-Data-Analysis?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Analyse des donn\u00e9es de s\u00e9quen\u00e7age de l'ADN<\/a> |<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Animal-Genetics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">G\u00e9n\u00e9tique animale<\/a> |<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Drug-Interactions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\"> Interactions m\u00e9dicamenteuses<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/genetics-and-genomics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">G\u00e9n\u00e9tique et g\u00e9nomique <\/a>|\u00a0<a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Consultants en dispositifs m\u00e9dicaux<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">R\u00e9dacteur m\u00e9dical ind\u00e9pendant<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">R\u00e9dacteur ind\u00e9pendant du CER<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Consultants MDR de l'UE<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Soumissions \u00e0 la FDA<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Experts en recherche documentaire<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Experts en conformit\u00e9 r\u00e9glementaire<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Expert en essais cliniques<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">R\u00e9dacteurs de textes r\u00e9glementaires<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Consultants PMS<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/country\/india\/subject\/post-market-clinical-followup?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Consultants du PMCF<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">\u00a0Experts en biostatistique<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">\u00a0Expert en d\u00e9veloppement de produits\u00a0<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Le Dr Harneet Arora, scientifique clinique ind\u00e9pendante et experte des r\u00e9glementations de la FDA, partage ses conseils sur la mani\u00e8re d'obtenir l'approbation de la FDA pour un nouveau m\u00e9dicament et sur la fa\u00e7on d'\u00e9viter les erreurs courantes.  La commercialisation d'un nouveau m\u00e9dicament aux \u00c9tats-Unis suit un parcours rigide. Chaque \u00e9tape du processus, de la recherche et du d\u00e9veloppement \u00e0 l'\u00e9tiquetage et \u00e0 l'autorisation de mise sur le march\u00e9, doit \u00eatre approuv\u00e9e par la FDA.<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/fr\/how-can-you-improve-your-chances-of-getting-fda-approval\/\" title=\"Lire la suite\">Lire la suite<\/a><\/div>","protected":false},"author":12,"featured_media":7063,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,304,443,540,653],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How can you improve your chances of getting FDA approval?<\/title>\n<meta name=\"description\" content=\"How to get FDA approval for your new drug: Top tips from FDA regulations expert and Kolabtree freelancer Dr. Harneet Arora.\" \/>\n<meta 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