{"id":30920,"date":"2022-08-05T07:26:47","date_gmt":"2022-08-05T13:26:47","guid":{"rendered":"https:\/\/brakkeconsulting.com\/?p=30920"},"modified":"2022-08-05T07:27:24","modified_gmt":"2022-08-05T13:27:24","slug":"brakke-viewpoint-august-5-2022","status":"publish","type":"post","link":"https:\/\/brakkeconsulting.com\/pt\/brakke-viewpoint-august-5-2022\/","title":{"rendered":"Brakke Viewpoint 5 de agosto de 2022"},"content":{"rendered":"<p>Neste espa\u00e7o, na semana passada, Bob Jones publicou um ponto de vista instigante sobre o tema das taxas de usu\u00e1rios de medicamentos para animais da FDA. Ele perguntou se os leitores achavam que os valores da taxa do usu\u00e1rio eram razo\u00e1veis. N\u00e3o surpreendentemente, 57% disse que as taxas s\u00e3o muito altas.<\/p>\n<p>Recentemente, li \u201cFlying Blind: The 737 MAX Tragedy and the Fall of Boeing\u201d de Peter Robison. Robison delineou as quest\u00f5es relacionadas ao 737 MAX e os acidentes resultantes. Um tema recorrente \u00e9 a pol\u00edtica da Federal Aviation Administration (FAA) de \u201cterceirizar\u201d a supervis\u00e3o do desenvolvimento de avi\u00f5es para os pr\u00f3prios fabricantes. A Boeing tomou decis\u00f5es sobre o desenvolvimento deste avi\u00e3o e o treinamento de seus pilotos que seriam vis\u00edveis para um regulador competente e independente; infelizmente, a FAA n\u00e3o teve compreens\u00e3o para contestar essas decis\u00f5es e 346 pessoas morreram em 2 acidentes, resultando no pouso do avi\u00e3o e em um dos esc\u00e2ndalos corporativos mais caros de todos os tempos.<\/p>\n<p>Ent\u00e3o\u2026 o que isso tem a ver com Sa\u00fade Animal? A ind\u00fastria concordou em apoiar os esfor\u00e7os da CVM por meio do sistema de Taxa do Usu\u00e1rio, mantendo a expertise e proporcionando seguran\u00e7a no processo de revis\u00e3o. Sim, pode custar muito dinheiro registrar um novo composto ou um novo medicamento gen\u00e9rico; no entanto, o sistema regulat\u00f3rio continua a ajudar nosso setor a manter uma posi\u00e7\u00e3o em nossa sociedade da qual podemos nos orgulhar. E isso tem um valor certamente real.<\/p>\n<p><em>Jim Kroman<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>Neste espa\u00e7o, na semana passada, Bob Jones publicou um ponto de vista instigante sobre o tema das taxas de uso de medicamentos para animais da FDA. Ele perguntou se os leitores achavam que os valores das taxas de usu\u00e1rio eram razo\u00e1veis. N\u00e3o surpreendentemente, 57% disse que as taxas s\u00e3o muito altas. Li recentemente \u201cFlying Blind: The 737 MAX Tragedy and the Fall of Boeing\u201d, de Peter Robison. Robison descreveu as quest\u00f5es relativas ao 737 MAX e os acidentes que resultaram. Um tema recorrente \u00e9 a pol\u00edtica da Administra\u00e7\u00e3o Federal de Avia\u00e7\u00e3o (FAA) de \u201cterceirizar\u201d a supervis\u00e3o do desenvolvimento de avi\u00f5es aos pr\u00f3prios fabricantes. A Boeing tomou decis\u00f5es sobre o desenvolvimento deste avi\u00e3o e a forma\u00e7\u00e3o dos seus pilotos que teriam sido vis\u00edveis para um regulador competente e independente; infelizmente, a FAA n\u00e3o teve a compreens\u00e3o necess\u00e1ria para contestar estas decis\u00f5es e 346 pessoas morreram em 2 acidentes, resultando na imobiliza\u00e7\u00e3o do avi\u00e3o e num dos esc\u00e2ndalos empresariais mais dispendiosos de sempre. Ent\u00e3o\u2026o que isso tem a ver com Sa\u00fade Animal? A ind\u00fastria concordou em apoiar os esfor\u00e7os da CVM por meio do sistema de Taxas de Usu\u00e1rio, mantendo a expertise e proporcionando seguran\u00e7a no processo de revis\u00e3o. Sim, pode custar muito dinheiro registar um novo composto ou um novo medicamento gen\u00e9rico; no entanto, o sistema regulat\u00f3rio continua a ajudar a nossa ind\u00fastria a manter uma posi\u00e7\u00e3o na nossa sociedade da qual podemos nos orgulhar<\/p>\n<div class=\"view-full-post\"><a href=\"https:\/\/brakkeconsulting.com\/pt\/brakke-viewpoint-august-5-2022\/\" class=\"view-full-post-btn\">Ver postagem completa<\/a><\/div>\n<p>;<\/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-30920","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-viewpoint-august-5-2022\/\" \/>\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=\"In this space last week, Bob Jones published a thought-provoking Viewpoint on the topic of FDA Animal Drug User Fees. He asked if readers felt that the User Fee amounts are reasonable. Not surprisingly, 57% said the fees are too high. I recently read &#8220;Flying Blind: The 737 MAX Tragedy and the Fall of Boeing&#8221; by Peter Robison. Robison outlined the issues regarding the 737 MAX and the accidents that resulted. A recurring theme is the policy of the Federal Aviation Administration (FAA) to &#8220;outsource&#8221; oversight of airplane development to the manufacturers themselves. Boeing made decisions about the development of this plane and the training for its pilots that would have been visible to a competent and independent regulator; unfortunately, the FAA lacked the understanding to challenge these decisions and 346 people died in 2 crashes, resulting in the grounding of the airplane and one of the costliest corporate scandals ever. So&#8230;what does this have to do with Animal Health? The industry agreed to support CVM&#8217;s efforts through the User Fee system maintaining expertise and providing for certainty in the review process. 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He asked if readers felt that the User Fee amounts are reasonable. Not surprisingly, 57% said the fees are too high. I recently read &#8220;Flying Blind: The 737 MAX Tragedy and the Fall of Boeing&#8221; by Peter Robison. Robison outlined the issues regarding the 737 MAX and the accidents that resulted. A recurring theme is the policy of the Federal Aviation Administration (FAA) to &#8220;outsource&#8221; oversight of airplane development to the manufacturers themselves. Boeing made decisions about the development of this plane and the training for its pilots that would have been visible to a competent and independent regulator; unfortunately, the FAA lacked the understanding to challenge these decisions and 346 people died in 2 crashes, resulting in the grounding of the airplane and one of the costliest corporate scandals ever. So&#8230;what does this have to do with Animal Health? 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Yes, it can take a lot of money to register a new compound or a new generic drug; however, the regulatory system continues to help our industry maintain a position in our society that we can be proudView Full Post;","og_url":"https:\/\/brakkeconsulting.com\/pt\/brakke-viewpoint-august-5-2022\/","og_site_name":"Brakke Consulting Website","article_published_time":"2022-08-05T13:26:47+00:00","article_modified_time":"2022-08-05T13:27:24+00:00","author":"Amanda McDavid","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"Amanda McDavid","Tempo estimado de leitura":"1 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/#article","isPartOf":{"@id":"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/"},"author":{"name":"Amanda McDavid","@id":"https:\/\/brakkeconsulting.com\/#\/schema\/person\/cbd3330707aa1f20925a2f9d78722615"},"headline":"Brakke Viewpoint August 5, 2022","datePublished":"2022-08-05T13:26:47+00:00","dateModified":"2022-08-05T13:27:24+00:00","mainEntityOfPage":{"@id":"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/"},"wordCount":232,"articleSection":["Viewpoints"],"inLanguage":"pt-PT"},{"@type":"WebPage","@id":"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/","url":"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/","name":"Not\u00edcias da Brakke Consulting","isPartOf":{"@id":"https:\/\/brakkeconsulting.com\/#website"},"datePublished":"2022-08-05T13:26:47+00:00","dateModified":"2022-08-05T13:27:24+00:00","author":{"@id":"https:\/\/brakkeconsulting.com\/#\/schema\/person\/cbd3330707aa1f20925a2f9d78722615"},"breadcrumb":{"@id":"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/#breadcrumb"},"inLanguage":"pt-PT","potentialAction":[{"@type":"ReadAction","target":["https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/brakkeconsulting.com\/"},{"@type":"ListItem","position":2,"name":"Brakke Viewpoint August 5, 2022"}]},{"@type":"WebSite","@id":"https:\/\/brakkeconsulting.com\/#website","url":"https:\/\/brakkeconsulting.com\/","name":"Site da Brakke Consulting","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/brakkeconsulting.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"pt-PT"},{"@type":"Person","@id":"https:\/\/brakkeconsulting.com\/#\/schema\/person\/cbd3330707aa1f20925a2f9d78722615","name":"Amanda McDavid","url":"https:\/\/brakkeconsulting.com\/pt\/author\/amanda\/"}]}},"_links":{"self":[{"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/posts\/30920","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/comments?post=30920"}],"version-history":[{"count":1,"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/posts\/30920\/revisions"}],"predecessor-version":[{"id":30921,"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/posts\/30920\/revisions\/30921"}],"wp:attachment":[{"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/media?parent=30920"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/categories?post=30920"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/brakkeconsulting.com\/pt\/wp-json\/wp\/v2\/tags?post=30920"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}