{"id":35892,"date":"2025-12-12T04:39:36","date_gmt":"2025-12-12T10:39:36","guid":{"rendered":"https:\/\/brakkeconsulting.com\/?p=35892"},"modified":"2026-01-09T11:00:29","modified_gmt":"2026-01-09T17:00:29","slug":"brakke-consulting-viewpoint-december-12-2025","status":"publish","type":"post","link":"https:\/\/brakkeconsulting.com\/pt\/brakke-consulting-viewpoint-december-12-2025\/","title":{"rendered":"Mirante de Brakke 12 de dezembro de 2025"},"content":{"rendered":"<p><span style=\"font-family: Arial,Helvetica;\" data-olk-copy-source=\"MessageBody\">Nas apresenta\u00e7\u00f5es Industry Overviews do pr\u00f3ximo ano, na VMX e na WVC, focaremos na inova\u00e7\u00e3o em sa\u00fade animal. Os recentes avan\u00e7os na sa\u00fade humana destacam os esfor\u00e7os para acelerar a inova\u00e7\u00e3o por meio da simplifica\u00e7\u00e3o dos processos regulat\u00f3rios, em vez de depender exclusivamente de avan\u00e7os impulsionados pelas empresas.<br \/>\n<\/span><\/p>\n<p><span style=\"font-family: Arial,Helvetica;\">Duas propostas not\u00e1veis surgiram: aprovar produtos para uso humano com base em um \u00fanico ensaio cl\u00ednico bem planejado, em vez de dois, e reduzir as taxas cobradas de empresas em est\u00e1gio inicial que realizam ensaios cl\u00ednicos nos EUA. Enquanto isso,\u00a0<u><a title=\"https:\/\/www.fiercebiotech.com\/biotech\/markets-thinking-backwards-fdas-1-trial-approval-plan-would-boost-rd-spend-jefferies\" href=\"https:\/\/www.fiercebiotech.com\/biotech\/markets-thinking-backwards-fdas-1-trial-approval-plan-would-boost-rd-spend-jefferies\" data-linkindex=\"74\" data-auth=\"NotApplicable\">primeira proposta<\/a><\/u>\u00a0Embora tenha gerado preocupa\u00e7\u00f5es, muitos acreditam que isso poderia fomentar a inova\u00e7\u00e3o, tornando as aprova\u00e7\u00f5es mais r\u00e1pidas e menos dispendiosas.\u00a0<u><a title=\"https:\/\/www.fiercebiotech.com\/biotech\/fda-floats-user-fee-cuts-early-stage-us-trials-additional-fees-overseas-development\" href=\"https:\/\/www.fiercebiotech.com\/biotech\/fda-floats-user-fee-cuts-early-stage-us-trials-additional-fees-overseas-development\" data-linkindex=\"75\" data-auth=\"NotApplicable\">segunda proposta<\/a><\/u> Refere-se \u00e0s negocia\u00e7\u00f5es em curso do PDUFA, cujos detalhes operacionais ainda est\u00e3o em discuss\u00e3o.\u00a0<\/span><\/p>\n<p><span style=\"font-family: Arial,Helvetica;\">Felizmente, essas iniciativas t\u00eam origem na pr\u00f3pria FDA. Grupos da ind\u00fastria de sa\u00fade humana tamb\u00e9m est\u00e3o contribuindo com ideias, e nossa pr\u00f3pria associa\u00e7\u00e3o de sa\u00fade animal (AHI) recomendou recentemente reformas regulat\u00f3rias e melhorias na efici\u00eancia dos processos para a Medicina Veterin\u00e1ria Cl\u00ednica. Com as negocia\u00e7\u00f5es da ADUFA come\u00e7ando no pr\u00f3ximo ano, a inova\u00e7\u00e3o regulat\u00f3ria em sa\u00fade animal pode estar pr\u00f3xima de se concretizar.\u00a0<\/span><\/p>\n<p><span style=\"font-family: Arial,Helvetica;\"><i>Robert Jones<\/i><\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Nas pr\u00f3ximas edi\u00e7\u00f5es do Industry Overviews, na VMX e na WVC, focaremos na inova\u00e7\u00e3o em sa\u00fade animal. Os recentes avan\u00e7os na sa\u00fade humana destacam os esfor\u00e7os para acelerar a inova\u00e7\u00e3o por meio da simplifica\u00e7\u00e3o dos processos regulat\u00f3rios, em vez de depender exclusivamente de avan\u00e7os impulsionados pelas empresas. Duas propostas not\u00e1veis surgiram: a aprova\u00e7\u00e3o de produtos para uso humano com base em um \u00fanico ensaio cl\u00ednico bem planejado, em vez de dois, e a redu\u00e7\u00e3o das taxas para empresas em est\u00e1gio inicial que realizam ensaios cl\u00ednicos nos EUA. Embora a primeira proposta tenha gerado preocupa\u00e7\u00f5es, muitos acreditam que ela pode fomentar a inova\u00e7\u00e3o, tornando as aprova\u00e7\u00f5es mais r\u00e1pidas e menos custosas. A segunda proposta est\u00e1 relacionada \u00e0s negocia\u00e7\u00f5es em andamento do PDUFA, com detalhes operacionais ainda em discuss\u00e3o. Felizmente, essas iniciativas t\u00eam origem na FDA. Grupos da ind\u00fastria de sa\u00fade humana tamb\u00e9m est\u00e3o contribuindo com ideias, e nossa pr\u00f3pria associa\u00e7\u00e3o de sa\u00fade animal (AHI) recomendou recentemente reformas regulat\u00f3rias e efici\u00eancia de processos para a Medicina Veterin\u00e1ria Cl\u00ednica (CVM). Com o in\u00edcio das negocia\u00e7\u00f5es do ADUFA no pr\u00f3ximo ano, a inova\u00e7\u00e3o regulat\u00f3ria em sa\u00fade animal pode estar pr\u00f3xima de se tornar realidade.<\/p>","protected":false},"author":19,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[43],"tags":[],"class_list":["post-35892","post","type-post","status-publish","format-standard","hentry","category-viewpoints"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>News from Brakke Consulting<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/brakkeconsulting.com\/pt\/brakke-consulting-viewpoint-december-12-2025\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"News from Brakke Consulting\" \/>\n<meta property=\"og:description\" content=\"At next year\u2019s Industry Overviews at VMX and WVC, we will focus on innovation in animal health. 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