{"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\/ja\/brakke-viewpoint-august-5-2022\/","title":{"rendered":"\u30d6\u30e9\u30c3\u30b1\u5c55\u671b\u53f0 2022 \u5e74 8 \u6708 5 \u65e5"},"content":{"rendered":"<p>\u5148\u9031\u3001\u3053\u306e\u30b9\u30da\u30fc\u30b9\u3067 Bob Jones \u6c0f\u304c FDA \u52d5\u7269\u7528\u533b\u85ac\u54c1\u30e6\u30fc\u30b6\u30fc\u6599\u91d1\u306b\u95a2\u3059\u308b\u8208\u5473\u6df1\u3044\u898b\u89e3\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u5f7c\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u6599\u91d1\u306e\u984d\u304c\u59a5\u5f53\u3067\u3042\u308b\u3068\u8aad\u8005\u304c\u611f\u3058\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u5c0b\u306d\u307e\u3057\u305f\u3002\u4e88\u60f3\u901a\u308a\u300157% \u6c0f\u306f\u6599\u91d1\u306f\u9ad8\u3059\u304e\u308b\u3068\u8ff0\u3079\u307e\u3057\u305f\u3002<\/p>\n<p>\u6700\u8fd1\u3001\u30d4\u30fc\u30bf\u30fc\u30fb\u30ed\u30d3\u30bd\u30f3\u8457\u306e\u300cFlying Blind: The 737 MAX Tragedy and the Fall of Boeing\u300d\u3092\u8aad\u307f\u307e\u3057\u305f\u3002\u30ed\u30d3\u30bd\u30f3\u306f\u3001737 MAX \u3068\u305d\u306e\u7d50\u679c\u751f\u3058\u305f\u4e8b\u6545\u306b\u95a2\u3059\u308b\u554f\u984c\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002\u7e70\u308a\u8fd4\u3057\u53d6\u308a\u4e0a\u3052\u3089\u308c\u3066\u3044\u308b\u30c6\u30fc\u30de\u306f\u3001\u822a\u7a7a\u6a5f\u958b\u767a\u306e\u76e3\u7763\u3092\u30e1\u30fc\u30ab\u30fc\u81ea\u8eab\u306b\u300c\u30a2\u30a6\u30c8\u30bd\u30fc\u30b9\u300d\u3059\u308b\u3068\u3044\u3046\u9023\u90a6\u822a\u7a7a\u5c40 (FAA) \u306e\u65b9\u91dd\u3067\u3059\u3002\u30dc\u30fc\u30a4\u30f3\u30b0\u306f\u3001\u3053\u306e\u822a\u7a7a\u6a5f\u306e\u958b\u767a\u3068\u30d1\u30a4\u30ed\u30c3\u30c8\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306b\u3064\u3044\u3066\u3001\u6709\u80fd\u3067\u72ec\u7acb\u3057\u305f\u898f\u5236\u5f53\u5c40\u304c\u76ee\u306b\u3059\u308b\u306f\u305a\u306e\u6c7a\u5b9a\u3092\u4e0b\u3057\u307e\u3057\u305f\u3002\u6b8b\u5ff5\u306a\u304c\u3089\u3001FAA \u306b\u306f\u3053\u308c\u3089\u306e\u6c7a\u5b9a\u306b\u7570\u8b70\u3092\u5531\u3048\u308b\u3060\u3051\u306e\u7406\u89e3\u304c\u306a\u304b\u3063\u305f\u305f\u3081\u30012 \u56de\u306e\u589c\u843d\u4e8b\u6545\u3067 346 \u4eba\u304c\u6b7b\u4ea1\u3057\u3001\u822a\u7a7a\u6a5f\u306e\u904b\u822a\u505c\u6b62\u3068\u53f2\u4e0a\u6700\u3082\u9ad8\u984d\u306a\u4f01\u696d\u30b9\u30ad\u30e3\u30f3\u30c0\u30eb\u306e 1 \u3064\u3068\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n<p>\u3067\u306f\u3001\u3053\u308c\u306f\u52d5\u7269\u306e\u5065\u5eb7\u306b\u3069\u306e\u3088\u3046\u306a\u95a2\u4fc2\u304c\u3042\u308b\u306e\u3067\u3057\u3087\u3046\u304b\u3002\u696d\u754c\u306f\u3001\u5c02\u9580\u77e5\u8b58\u3092\u7dad\u6301\u3057\u3001\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u306e\u78ba\u5b9f\u6027\u3092\u63d0\u4f9b\u3059\u308b\u30e6\u30fc\u30b6\u30fc\u6599\u91d1\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066 CVM 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Blind: The 737 MAX Tragedy and the Fall of Boeing\uff08\u76f2\u76ee\u7684\u98db\u884c\uff1a737 MAX\u306e\u60b2\u5287\u3068\u30dc\u30fc\u30a4\u30f3\u30b0\u306e\u6ca1\u843d\uff09\u300d\u3092\u8aad\u307f\u307e\u3057\u305f\u3002\u30ed\u30d3\u30bd\u30f3\u6c0f\u306f737 MAX\u3068\u305d\u306e\u4e8b\u6545\u306b\u95a2\u3059\u308b\u554f\u984c\u70b9\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u3053\u3067\u7e70\u308a\u8fd4\u3057\u53d6\u308a\u4e0a\u3052\u3089\u308c\u308b\u30c6\u30fc\u30de\u306f\u3001\u9023\u90a6\u822a\u7a7a\u5c40\uff08FAA\uff09\u304c\u822a\u7a7a\u6a5f\u958b\u767a\u306e\u76e3\u7763\u3092\u30e1\u30fc\u30ab\u30fc\u81ea\u8eab\u306b\u300c\u30a2\u30a6\u30c8\u30bd\u30fc\u30b7\u30f3\u30b0\u300d\u3059\u308b\u3068\u3044\u3046\u65b9\u91dd\u3067\u3059\u3002\u30dc\u30fc\u30a4\u30f3\u30b0\u793e\u306f\u3001\u3053\u306e\u822a\u7a7a\u6a5f\u306e\u958b\u767a\u3068\u30d1\u30a4\u30ed\u30c3\u30c8\u306e\u8a13\u7df4\u306b\u95a2\u3059\u308b\u6c7a\u5b9a\u3092\u4e0b\u3057\u307e\u3057\u305f\u304c\u3001\u305d\u306e\u6c7a\u5b9a\u306f\u6709\u80fd\u3067\u72ec\u7acb\u3057\u305f\u898f\u5236\u5f53\u5c40\u3067\u3042\u308c\u3070\u660e\u3089\u304b\u3060\u3063\u305f\u306f\u305a\u3067\u3059\u3002\u3057\u304b\u3057\u6b8b\u5ff5\u306a\u304c\u3089\u3001FAA\u306b\u306f\u3053\u308c\u3089\u306e\u6c7a\u5b9a\u306b\u7570\u8b70\u3092\u5531\u3048\u308b\u3060\u3051\u306e\u7406\u89e3\u529b\u304c\u306a\u304f\u30012\u4ef6\u306e\u589c\u843d\u4e8b\u6545\u3067346\u4eba\u304c\u6b7b\u4ea1\u3057\u3001\u540c\u6a5f\u306e\u904b\u822a\u505c\u6b62\u306f\u53f2\u4e0a\u6700\u60aa\u306e\u4f01\u696d\u30b9\u30ad\u30e3\u30f3\u30c0\u30eb\u306e\u4e00\u3064\u3068\u306a\u308a\u307e\u3057\u305f\u3002\u3067\u306f\u2026\u3053\u308c\u306f\u52d5\u7269\u885b\u751f\u3068\u3069\u3046\u95a2\u4fc2\u304c\u3042\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u696d\u754c\u306f\u3001\u5c02\u9580\u77e5\u8b58\u3092\u7dad\u6301\u3057\u3001\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u306e\u78ba\u5b9f\u6027\u3092\u78ba\u4fdd\u3059\u308b\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u5236\u5ea6\u3092\u901a\u3058\u3066\u3001CVM\u306e\u53d6\u308a\u7d44\u307f\u3092\u652f\u63f4\u3059\u308b\u3053\u3068\u306b\u540c\u610f\u3057\u307e\u3057\u305f\u3002\u78ba\u304b\u306b\u3001\u65b0\u898f\u5316\u5408\u7269\u3084\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u767b\u9332\u306b\u306f\u591a\u984d\u306e\u8cbb\u7528\u304c\u304b\u304b\u308a\u307e\u3059\u304c\u3001\u898f\u5236\u5236\u5ea6\u306f\u3001\u79c1\u305f\u3061\u306e\u696d\u754c\u304c\u793e\u4f1a\u306b\u304a\u3044\u3066\u8a87\u308a\u3042\u308b\u5730\u4f4d\u3092\u7dad\u6301\u3059\u308b\u4e0a\u3067\u5f15\u304d\u7d9a\u304d\u5f79\u7acb\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<div class=\"view-full-post\"><a href=\"https:\/\/brakkeconsulting.com\/ja\/brakke-viewpoint-august-5-2022\/\" class=\"view-full-post-btn\">\u5168\u6587\u3092\u898b\u308b<\/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\/ja\/brakke-viewpoint-august-5-2022\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\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. 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;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/brakkeconsulting.com\/ja\/brakke-viewpoint-august-5-2022\/\" \/>\n<meta property=\"og:site_name\" content=\"Brakke Consulting Website\" \/>\n<meta property=\"article:published_time\" content=\"2022-08-05T13:26:47+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-08-05T13:27:24+00:00\" \/>\n<meta name=\"author\" content=\"Amanda McDavid\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Amanda McDavid\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@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\":\"ja\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/\",\"url\":\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/\",\"name\":\"News from 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\":\"ja\",\"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\":\"Brakke Consulting Website\",\"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\":\"ja\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/brakkeconsulting.com\/#\/schema\/person\/cbd3330707aa1f20925a2f9d78722615\",\"name\":\"Amanda McDavid\",\"url\":\"https:\/\/brakkeconsulting.com\/ja\/author\/amanda\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Brakke Consulting\u304b\u3089\u306e\u30cb\u30e5\u30fc\u30b9","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/brakkeconsulting.com\/ja\/brakke-viewpoint-august-5-2022\/","og_locale":"ja_JP","og_type":"article","og_title":"News from Brakke Consulting","og_description":"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. 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\/ja\/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":{"\u57f7\u7b46\u8005":"Amanda McDavid","\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593":"1\u5206"},"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":"ja"},{"@type":"WebPage","@id":"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/","url":"https:\/\/brakkeconsulting.com\/brakke-viewpoint-august-5-2022\/","name":"Brakke Consulting\u304b\u3089\u306e\u30cb\u30e5\u30fc\u30b9","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":"ja","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":"Brakke Consulting\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8","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":"ja"},{"@type":"Person","@id":"https:\/\/brakkeconsulting.com\/#\/schema\/person\/cbd3330707aa1f20925a2f9d78722615","name":"\u30a2\u30de\u30f3\u30c0\u30fb\u30de\u30af\u30c7\u30a4\u30d3\u30c3\u30c9","url":"https:\/\/brakkeconsulting.com\/ja\/author\/amanda\/"}]}},"_links":{"self":[{"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/posts\/30920","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/comments?post=30920"}],"version-history":[{"count":1,"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/posts\/30920\/revisions"}],"predecessor-version":[{"id":30921,"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/posts\/30920\/revisions\/30921"}],"wp:attachment":[{"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/media?parent=30920"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/categories?post=30920"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/brakkeconsulting.com\/ja\/wp-json\/wp\/v2\/tags?post=30920"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}