{"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\/pt\/how-can-you-improve-your-chances-of-getting-fda-approval\/","title":{"rendered":"Como voc\u00ea pode melhorar suas chances de obter a aprova\u00e7\u00e3o da 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\">Tabela de Conte\u00fados<\/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-69f1ad0746bdd\" aria-label=\"Table of Content\"><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-69f1ad0746bdd\"><\/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\/pt\/how-can-you-improve-your-chances-of-getting-fda-approval\/#1_Organise_your_paperwork\" title=\"1. Organize sua papelada\">1. Organize sua papelada<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-can-you-improve-your-chances-of-getting-fda-approval\/#2_Present_measurable_evidence\" title=\"2. Apresentar evid\u00eancias mensur\u00e1veis\">2. Apresentar evid\u00eancias mensur\u00e1veis<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-can-you-improve-your-chances-of-getting-fda-approval\/#3_Keep_a_thorough_record\" title=\"3. Mantenha um registro completo\">3. Mantenha um registro completo<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-can-you-improve-your-chances-of-getting-fda-approval\/#Final_considerations\" title=\"Considera\u00e7\u00f5es finais\">Considera\u00e7\u00f5es finais<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Dra. Harneet Arora, cientista cl\u00ednica freelancer e <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\">Especialista em normas FDA<\/a>A Dra. Kelly, compartilha seus conselhos sobre como obter a aprova\u00e7\u00e3o da FDA para um novo medicamento e como evitar erros comuns.\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\/pt\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">pesquisa<\/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>De acordo com um estudo recente do Instituto de Tecnologia de Massachusetts, apenas cerca de 14% de todos os medicamentos em ensaios cl\u00ednicos recebem aprova\u00e7\u00e3o da FDA, a ag\u00eancia federal dos EUA respons\u00e1vel pela prote\u00e7\u00e3o e promo\u00e7\u00e3o da sa\u00fade p\u00fablica. Isto significa que para 86% de todos os novos medicamentos propostos, algo d\u00e1 errado ao longo do processo de comercializa\u00e7\u00e3o, desperdi\u00e7ando tempo, energia e capital.<\/p><\/blockquote>\n<p>Ent\u00e3o, quais s\u00e3o os erros evit\u00e1veis mais comuns ao solicitar a aprova\u00e7\u00e3o da FDA e o que os candidatos podem fazer para evitar que eles ocorram? <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/harneet-arora-pt\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Dra. Harneet Arora<\/a>, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\">perito em apresenta\u00e7\u00f5es da FDA por conta pr\u00f3pria<\/a> em Kolabtree, compartilha suas melhores dicas.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Organise_your_paperwork\"><\/span>1. Organize sua papelada<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>O primeiro erro - e o mais f\u00e1cil de evitar - \u00e9 apresentar uma aplica\u00e7\u00e3o incompleta. Verifique o <a href=\"https:\/\/www.fda.gov\/drugs\/types-applications\/new-drug-application-nda\">Site da FDA<\/a> para ter certeza de que voc\u00ea est\u00e1 enviando todos os formul\u00e1rios exigidos e que eles est\u00e3o completamente preenchidos. Preste aten\u00e7\u00e3o extra ao preencher o formul\u00e1rio 1572, um dos principais documentos de sua apresenta\u00e7\u00e3o de investiga\u00e7\u00e3o de novos medicamentos (IND).<\/p>\n<p>O formul\u00e1rio 1572 garante que os candidatos n\u00e3o tenham nenhum preconceito ou conflito de interesses, que concordem em seguir o C\u00f3digo de Regulamenta\u00e7\u00e3o Federal da FDA para ensaios cl\u00ednicos e que tenham a experi\u00eancia necess\u00e1ria para conduzir o estudo de uma forma \u00e9tica e cientificamente rigorosa. Evitar erros neste formul\u00e1rio evitar\u00e1 um atraso posterior.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Present_measurable_evidence\"><\/span>2. Apresentar evid\u00eancias mensur\u00e1veis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Ap\u00f3s todas as fases de um ensaio cl\u00ednico terem sido conclu\u00eddas, a FDA analisar\u00e1 os resultados e organizar\u00e1 uma discuss\u00e3o aberta - muitas vezes virtualmente - onde as empresas farmac\u00eauticas apresentem evid\u00eancias de que o medicamento proposto \u00e9 eficaz e oferece vantagens significativas sobre os medicamentos existentes para a mesma doen\u00e7a. Aqui o objetivo n\u00e3o \u00e9 estabelecer se o novo medicamento ser\u00e1 seguro - isto j\u00e1 foi determinado com estudos in vitro e in vivo - mas provar que ele melhorar\u00e1 significativamente a vida dos pacientes.<\/p>\n<p>Em minha experi\u00eancia, a maioria das rejei\u00e7\u00f5es acontece nesta fase devido \u00e0 falta de dados claros sobre a efic\u00e1cia do medicamento e sobre como ele \u00e9 melhor do que os tratamentos j\u00e1 comercializados. Como tal, \u00e9 importante apresentar par\u00e2metros mensur\u00e1veis sobre a efic\u00e1cia do medicamento.<\/p>\n<blockquote><p>Por exemplo, n\u00e3o basta indicar que os sintomas dos pacientes melhoraram em 2%, \u00e9 necess\u00e1rio especificar a natureza dessa melhoria.<\/p><\/blockquote>\n<p>Tamb\u00e9m \u00e9 importante fornecer um quadro de refer\u00eancia para avaliar essa melhoria. Isto pode ser uma compara\u00e7\u00e3o entre um grupo de pacientes que tomam o novo medicamento e um grupo de controle que toma um placebo, ou um grupo que toma um medicamento que j\u00e1 se encontra no mercado.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Keep_a_thorough_record\"><\/span>3. Mantenha um registro completo<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u00c9 essencial documentar adequadamente cada etapa do desenvolvimento e teste de um novo medicamento, desde dados pr\u00e9-cl\u00ednicos precisos sobre estudos in vitro e em animais, at\u00e9 como a dose inicial e m\u00e1xima recomendada foi estabelecida. Os candidatos tamb\u00e9m devem provar que o medicamento foi testado em um n\u00famero adequado de sujeitos e devem documentar cuidadosamente como reagiram ao tratamento. Em particular, os candidatos devem sinalizar quaisquer efeitos colaterais adversos que os sujeitos tenham experimentado. Se alguns dos sujeitos decidirem desistir do tratamento, os requerentes devem explicar por que isso aconteceu.<\/p>\n<blockquote><p>Tamb\u00e9m \u00e9 necess\u00e1rio provar que os benef\u00edcios do novo medicamento superam seus efeitos colaterais e que estes s\u00e3o menos severos que os de medicamentos j\u00e1 comercializados para a mesma doen\u00e7a. Por exemplo, um medicamento para tratar uma doen\u00e7a terminal que provoca v\u00f4mitos e enxaquecas ainda pode ser aprovado se aumentar significativamente a expectativa de vida dos pacientes. Se os mesmos efeitos colaterais fossem relatados para um medicamento para tratar a hipertens\u00e3o, a aprova\u00e7\u00e3o provavelmente seria negada, j\u00e1 que j\u00e1 existem tratamentos no mercado para essa condi\u00e7\u00e3o com menores efeitos colaterais.<\/p><\/blockquote>\n<p>Em qualquer caso, os requerentes t\u00eam que apresentar suas estrat\u00e9gias de avalia\u00e7\u00e3o e mitiga\u00e7\u00e3o de riscos (REMS), onde devem explicar detalhadamente que medidas est\u00e3o planejando tomar para minimizar eventuais efeitos colaterais. Ao compilar esta se\u00e7\u00e3o, certifique-se de ser o mais espec\u00edfico poss\u00edvel sobre o que os pacientes precisam fazer para evitar efeitos colaterais, por exemplo, descreva se precisam usar contracep\u00e7\u00e3o ao se submeterem ao tratamento e, em caso afirmativo, de que tipo.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Final_considerations\"><\/span>Considera\u00e7\u00f5es finais<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>Para que o novo medicamento seja aprovado, pelo menos 80% de sujeitos no julgamento devem apresentar sinais de melhora.<\/strong> Para garantir que esta evid\u00eancia seja apresentada corretamente e que o grupo de amostra seja suficientemente grande para fornecer dados significativos, os candidatos podem precisar da assist\u00eancia de um especialista em estat\u00edstica. Nesta fase, as empresas que n\u00e3o t\u00eam um estat\u00edstico interno devem considerar a colabora\u00e7\u00e3o com um freelancer, que pode ajud\u00e1-los na sele\u00e7\u00e3o do grupo de amostra e na coleta e an\u00e1lise dos dados cl\u00ednicos.<\/p>\n<p>Finalmente, \u00e9 importante ter em mente que a qualquer momento a FDA pode auditar as instala\u00e7\u00f5es onde o medicamento est\u00e1 sendo desenvolvido e testado, para certificar-se de que ele est\u00e1 em conformidade com as diretrizes de boas pr\u00e1ticas cl\u00ednicas (GCP). Por exemplo, durante uma auditoria, a FDA pode verificar se todo o pessoal tem as qualifica\u00e7\u00f5es necess\u00e1rias para cumprir suas tarefas com seguran\u00e7a.<\/p>\n<p>Solicitar a aprova\u00e7\u00e3o da FDA pode ser um desmancha-prazeres, mas consultar especialistas que t\u00eam um conhecimento detalhado dos procedimentos da FDA pode agilizar o processo. Algumas empresas farmac\u00eauticas podem ter um departamento de regulamenta\u00e7\u00e3o interno apenas para esse fim, mas as empresas menores podem n\u00e3o ter a capacidade e o or\u00e7amento para tal investimento. Nesse caso, contratar um especialista aut\u00f4nomo pode ser a solu\u00e7\u00e3o.<\/p>\n<p><strong>Kolabtree ajuda voc\u00ea a contratar especialistas da FDA e <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">redatores freelance de regulamenta\u00e7\u00e3o<\/a>sob demanda. <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA#create-project\">Publique seu projeto e receba or\u00e7amentos de gra\u00e7a<\/a>.\u00a0<\/strong><\/p>\n<p><strong>Peritos relacionados:\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\">Profissional liberal da bioinform\u00e1tica<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Plant-Genetics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Gen\u00e9tica vegetal<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Developmental-Biology?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Biologia do Desenvolvimento<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Gene-Therapy?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Terapia gen\u00e9tica<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Stem-Cells?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">C\u00e9lulas-tronco <\/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\">An\u00e1lise de dados de seq\u00fcenciamento de DNA<\/a> |<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Animal-Genetics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Gen\u00e9tica animal<\/a> |<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Drug-Interactions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\"> Intera\u00e7\u00f5es medicamentosas<\/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\">Gen\u00e9tica e Gen\u00f4mica <\/a>|\u00a0<a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Consultores de Produtos m\u00e9dicos<\/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\">Escritor M\u00e9dico Freelancer<\/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\">Escritor aut\u00f4nomo do 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\">Consultores MDR da 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\">Envios da FDA<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=HowtoApplyFDA\">Especialistas em Pesquisa de Literatura<\/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\">Peritos em Conformidade Regulat\u00f3ria<\/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\">Especialista em ensaios cl\u00ednicos<\/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\">Escritores Reguladores<\/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\">Consultores 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\">Consultores da 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\">\u00a0Especialistas em Bioestat\u00edstica<\/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\">\u00a0Especialista em desenvolvimento de produtos\u00a0<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>A Dra. Harneet Arora, cientista cl\u00ednica freelance e especialista em regulamentos do FDA, compartilha seus conselhos sobre como obter a aprova\u00e7\u00e3o do FDA para um novo medicamento e como evitar erros comuns.  A comercializa\u00e7\u00e3o de um novo medicamento nos Estados Unidos segue um caminho r\u00edgido. Cada passo ao longo do processo, da pesquisa e desenvolvimento \u00e0 rotulagem e<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/how-can-you-improve-your-chances-of-getting-fda-approval\/\" title=\"Leia mais\">Leia mais<\/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 name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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