{"id":30892,"date":"2022-07-29T07:15:52","date_gmt":"2022-07-29T13:15:52","guid":{"rendered":"https:\/\/brakkeconsulting.com\/?p=30892"},"modified":"2022-07-29T07:16:54","modified_gmt":"2022-07-29T13:16:54","slug":"brakke-viewpoint-july-29-2022","status":"publish","type":"post","link":"https:\/\/brakkeconsulting.com\/ja\/brakke-viewpoint-july-29-2022\/","title":{"rendered":"\u30d6\u30e9\u30c3\u30b1\u5c55\u671b\u53f0 2022 \u5e74 7 \u6708 29 \u65e5"},"content":{"rendered":"<p>FDA \u306e\u52d5\u7269\u7528\u533b\u85ac\u54c1\u4f7f\u7528\u6599\u304c\u9ad8\u3044\u3068\u52d5\u7269\u7528\u533b\u85ac\u54c1\u306e\u9769\u65b0\u304c\u9045\u308c\u308b\u306e\u3067\u3057\u3087\u3046\u304b?<\/p>\n<p>FDA ADUFA\/AGDUFA \u6599\u91d1\u306f\u3001\u30a4\u30f3\u30d5\u30ec\u3001\u4f5c\u696d\u8ca0\u8377\u3001\u524d\u5e74\u5ea6\u306e\u5fb4\u53ce\u984d\u306e\u8d85\u904e\u307e\u305f\u306f\u4e0d\u8db3\u306b\u3088\u308a\u6bce\u5e74\u5909\u66f4\u3055\u308c\u307e\u3059\u300210 \u6708\u304b\u3089\u3001\u65b0\u898f\u52d5\u7269\u7528\u533b\u85ac\u54c1\u7533\u8acb\u306b\u306f $659,364 \u306e\u30c1\u30a7\u30c3\u30af\u304c\u5fc5\u8981\u3068\u306a\u308a\u3001\u88dc\u8db3\u7533\u8acb\u306b\u306f $329,682 \u306e\u30c1\u30a7\u30c3\u30af\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u6628\u5e74\u3088\u308a 13.5% \u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1 ANADA \u306b\u306f 2023 \u5e74\u306b $494,983 \u306e\u30c1\u30a7\u30c3\u30af\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u304c\u3001\u3053\u308c\u306f\u4e3b\u306b 2021 \u5e74\u306e\u5fb4\u53ce\u984d\u306e\u8d85\u904e\u306b\u3088\u308a\u30012022 \u5e74\u306e $548,628 \u304b\u3089\u6e1b\u5c11\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u591a\u984d\u306e\u91d1\u984d\u3067\u3042\u308a\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u306b\u9055\u3044\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306b\u95a2\u3059\u308b\u8208\u5473\u6df1\u3044\u60c5\u5831\u306f\u3001\u4f5c\u696d\u8ca0\u8377\u306e\u8a08\u7b97\u304b\u3089\u5f97\u3089\u308c\u307e\u3059\u3002\u904e\u53bb 5 \u5e74\u9593 (2022 \u5e74 5 \u6708\u307e\u3067) \u306b\u63d0\u51fa\u3055\u308c\u305f NADA \u306e\u5e73\u5747\u6570\u306f 12.8 \u3067\u30012018 \u5e74 9 \u6708\u307e\u3067\u306e 5 \u5e74\u9593 (\u5e73\u5747 16.4 \u4ef6) \u3068\u6bd4\u8f03\u3059\u308b\u3068 22% \u6e1b\u5c11\u3057\u3066\u3044\u307e\u3059\u3002FDA \u306f\u30012023 \u5e74\u306b 5.25 \u306e NADA \u3092\u4e88\u60f3\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u540c\u3058 5 \u5e74\u9593\u3092\u6bd4\u8f03\u3059\u308b\u3068\u3001\u88dc\u8db3\u7533\u8acb\u3082 22% \u6e1b\u5c11\u3057\u3001\u8abf\u67fb\u7814\u7a76\u306e\u63d0\u51fa\u306f 7% \u6e1b\u5c11\u3057\u3001\u88fd\u9020\u88dc\u8db3\u306f 4% \u5897\u52a0\u3057\u3001\u8abf\u67fb\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u63d0\u51fa\u306f 1% \u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u3059\u3079\u3066\u306b\u3088\u308a\u3001\u4f5c\u696d\u8ca0\u8377\u306f\u5168\u4f53\u3067 4.5% \u6e1b\u5c11\u3057\u307e\u3059\u304c\u3001\u3053\u308c\u306f\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u9762\u3067\u306f\u3042\u307e\u308a\u826f\u3044\u7d50\u679c\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>\u3057\u304b\u3057\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u52d5\u7269\u7528\u533b\u85ac\u54c1\u306e\u4f5c\u696d\u91cf\u306f\u6025\u5897\u3057\u3066\u304a\u308a\u300177% \u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u540c\u3058 2 \u3064\u306e 5 \u5e74\u9593\u3067\u3001ANADA \u306f 12.5% (27 \u5bfe 24) \u5897\u52a0\u3057\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u306e\u6cbb\u9a13\u7533\u8acb\u306f 125% \u5897\u52a0\u3057\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u306e\u6cbb\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u7533\u8acb\u306f 77%\u3001\u88fd\u9020\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306f 30% \u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002FDA \u306f\u30012023 \u5e74\u306b\u306f\u3001NADA \u306e 2 \u500d\u3068\u306a\u308b 11.6 \u4ef6\u306e\u5168\u984d\u8ca0\u62c5\u306e ANADA \u304c\u7533\u8acb\u3055\u308c\u308b\u3068\u4e88\u6e2c\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u3064\u307e\u308a\u3001\u30ea\u30b9\u30af\u304c\u4f4e\u304f\u3001\u30b3\u30b9\u30c8\u306e\u5b89\u3044\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u958b\u767a\u304c\u3001\u30ea\u30b9\u30af\u304c\u9ad8\u304f\u3001\u30b3\u30b9\u30c8\u306e\u9ad8\u3044\u65b0\u85ac\u306e\u958b\u767a\u306b\u53d6\u3063\u3066\u4ee3\u308f\u3063\u305f\u306e\u3067\u3059\u3002\u88fd\u54c1\u304c\u9769\u65b0\u7684\u3067\u3042\u308b\u3068\u307f\u306a\u3055\u308c\u3001\u6599\u91d1\u304c\u88fd\u54c1\u3092\u5e02\u5834\u306b\u51fa\u3059\u4e0a\u3067\u5927\u304d\u306a\u969c\u5bb3\u3068\u306a\u308b\u5834\u5408\u3001\u6599\u91d1\u3092\u514d\u9664\u307e\u305f\u306f\u6e1b\u984d\u3059\u308b\u898f\u5b9a\u304c\u3042\u308a\u307e\u3059\u3002FDA \u306b\u63d0\u51fa\u3055\u308c\u3001\u6599\u91d1\u304c\u514d\u9664\u3055\u308c\u305f NADA \u306e\u6570\u306f FDA \u306b\u3088\u3063\u3066\u516c\u8868\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u304c\u3001\u79c1\u305f\u3061\u306f\u305d\u306e\u6570\u306f\u308f\u305a\u304b\u3067\u3042\u308b\u3068\u60f3\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u4eca\u5e74\u306f ADUFA IV \u306e\u6700\u7d42\u5e74\u3067\u3042\u308a\u3001\u73fe\u5728\u30012024 \u5e74\u5ea6\u306b\u958b\u59cb\u3055\u308c\u308b ADUFA V \u306e\u4ea4\u6e09\u304c\u9032\u884c\u4e2d\u3067\u3059\u3002\u3055\u3089\u306a\u308b\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u63a8\u9032\u3067\u304d\u308b\u69cb\u9020\u306b\u306a\u308b\u3053\u3068\u3092\u671f\u5f85\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n<p><em>\u30dc\u30d6\u30fb\u30b8\u30e7\u30fc\u30f3\u30ba<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>FDA\u306e\u52d5\u7269\u7528\u533b\u85ac\u54c1\u30e6\u30fc\u30b6\u30fc\u30ba\u30d5\u30a3\u30fc\uff08ADUFA\/AGDUFA\uff09\u306e\u9ad8\u984d\u306a\u6599\u91d1\u306f\u3001\u52d5\u7269\u7528\u533b\u85ac\u54c1\u306e\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u3092\u963b\u5bb3\u3059\u308b\u306e\u3067\u3057\u3087\u3046\u304b\uff1fFDA\u306eADUFA\/AGDUFA\u6599\u91d1\u306f\u3001\u30a4\u30f3\u30d5\u30ec\u3001\u4f5c\u696d\u91cf\u3001\u524d\u5e74\u5ea6\u306e\u5fb4\u53ce\u984d\u306e\u8d85\u904e\u307e\u305f\u306f\u4e0d\u8db3\u306b\u3088\u308a\u6bce\u5e74\u5909\u52d5\u3057\u307e\u3059\u300210\u6708\u304b\u3089\u3001\u65b0\u898f\u52d5\u7269\u7528\u533b\u85ac\u54c1\u7533\u8acb\u306b\u306f$659,364\u3001\u8ffd\u52a0\u7533\u8acb\u306b\u306f$329,682\u306e\u30c1\u30a7\u30c3\u30af\u304c\u5fc5\u8981\u3068\u306a\u308a\u3001\u6628\u5e74\u3088\u308a13.5%\u5897\u52a0\u3057\u307e\u3059\u3002\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306eANADA\uff08\u52d5\u7269\u7528\u533b\u85ac\u54c1\u30e6\u30fc\u30b6\u30fc\u30ba\u30d5\u30a3\u30fc\uff09\u306f\u30012021\u5e74\u306e\u5fb4\u53ce\u984d\u8d85\u904e\u306e\u5f71\u97ff\u306b\u3088\u308a\u30012022\u5e74\u306e$548,628\u304b\u30892023\u5e74\u306b\u306f$494,983\u306e\u30c1\u30a7\u30c3\u30af\u304c\u5fc5\u8981\u306b\u306a\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u591a\u984d\u306e\u91d1\u984d\u3067\u3042\u308a\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3053\u3068\u306f\u9593\u9055\u3044\u3042\u308a\u307e\u305b\u3093\u3002\u4f5c\u696d\u91cf\u8a08\u7b97\u304b\u3089\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306b\u95a2\u3059\u308b\u8208\u5473\u6df1\u3044\u60c5\u5831\u304c\u5f97\u3089\u308c\u307e\u3059\u3002\u904e\u53bb5\u5e74\u9593\uff082022\u5e745\u6708\u307e\u3067\uff09\u306b\u63d0\u51fa\u3055\u308c\u305fNADA\uff08\u975e\u533b\u85ac\u54c1\u958b\u767a\u7533\u8acb\uff09\u306e\u5e73\u5747\u4ef6\u6570\u306f12.8\u4ef6\u3067\u30012018\u5e749\u6708\u307e\u3067\u306e5\u5e74\u9593\u306e\u5e73\u574716.4\u4ef6\u3068\u6bd4\u8f03\u3057\u306622%\u6e1b\u5c11\u3057\u3066\u3044\u307e\u3059\u3002FDA\u306f2023\u5e74\u306eNADA\u4ef6\u6570\u30925.25\u4ef6\u3068\u4e88\u6e2c\u3057\u3066\u3044\u307e\u3059\u3002\u540c\u30585\u5e74\u9593\u3092\u6bd4\u8f03\u3059\u308b\u3068\u3001\u8ffd\u52a0\u7533\u8acb\u308222%\u6e1b\u5c11\u3001\u6cbb\u9a13\u7533\u8acb\u306f7%\u6e1b\u5c11\u3001\u88fd\u9020\u88dc\u52a9\u7533\u8acb\u306f4%\u5897\u52a0\u3001\u6cbb\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u7533\u8acb\u306f1%\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u5168\u3066\u304c\u3001\u5168\u4f53\u30674.5%\u306e\u4f5c\u696d\u91cf\u306e\u6e1b\u5c11\u306b\u3064\u306a\u304c\u308a\u3001\u3053\u308c\u306f\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u9032\u5c55\u3092\u53cd\u6620\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u52d5\u7269\u7528\u533b\u85ac\u54c1\u306e\u4f5c\u696d\u91cf\u306f\u6025\u5897\u3057\u3066\u304a\u308a\u300177%\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u540c\u30582\u3064\u306e5\u5e74\u9593\u3067\u3001ANADA\u306f12.5%\uff0827\u5bfe24\uff09\u5897\u52a0\u3057\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u306e\u6cbb\u9a13\u7533\u8acb\u306f<\/p>\n<div class=\"view-full-post\"><a href=\"https:\/\/brakkeconsulting.com\/ja\/brakke-viewpoint-july-29-2022\/\" 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-30892","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-july-29-2022\/\" \/>\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=\"Do high FDA Animal Drug Users Fees slow innovation in animal drugs? Each year the FDA ADUFA\/AGDUFA fees change due to inflation, workload, and prior year excesses or shortfalls in collections.\u00a0 Starting in October, New Animal Drug Applications will require a $659,364 check and a supplemental application will need a $329,682 check, 13.5% more than last year.\u00a0 A generic drug ANADA will need a $494,983 check in 2023, down from $548,628 in 2022 due primarily to excess collections in 2021.\u00a0 That\u2019s a lot of money and it must impact innovation. Some interesting information on innovation comes from the workload calculation.\u00a0 The average number of NADAs submitted over the last 5 years (ending May 2022) is 12.8, which is down 22% compared to the 5 years ending September 2018, which had an average of 16.4 applications.\u00a0 The FDA expects 5.25 NADAs in 2023.\u00a0 Comparing these same 5-year periods to each other, supplemental applications are down 22% also, investigational study submissions are down 7%, manufacturing supplements are up 4% and investigational protocol submissions are up 1%.\u00a0 This all leads to an overall 4.5% reduction in workload, which doesn\u2019t reflect well on innovation. However, the workload for Generic Animal Drugs is booming \u2013 it\u2019s up 77%. Over these same two 5-year periods, ANADAs are up 12.5% (27 vs 24), generic investigational study submissionsView Full Post;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/brakkeconsulting.com\/ja\/brakke-viewpoint-july-29-2022\/\" \/>\n<meta property=\"og:site_name\" content=\"Brakke Consulting Website\" \/>\n<meta property=\"article:published_time\" content=\"2022-07-29T13:15:52+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-07-29T13:16:54+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=\"2\u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-july-29-2022\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-july-29-2022\/\"},\"author\":{\"name\":\"Amanda McDavid\",\"@id\":\"https:\/\/brakkeconsulting.com\/ja\/#\/schema\/person\/cbd3330707aa1f20925a2f9d78722615\"},\"headline\":\"Brakke Viewpoint July 29, 2022\",\"datePublished\":\"2022-07-29T13:15:52+00:00\",\"dateModified\":\"2022-07-29T13:16:54+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-july-29-2022\/\"},\"wordCount\":334,\"articleSection\":[\"Viewpoints\"],\"inLanguage\":\"ja\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-july-29-2022\/\",\"url\":\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-july-29-2022\/\",\"name\":\"News from Brakke Consulting\",\"isPartOf\":{\"@id\":\"https:\/\/brakkeconsulting.com\/ja\/#website\"},\"datePublished\":\"2022-07-29T13:15:52+00:00\",\"dateModified\":\"2022-07-29T13:16:54+00:00\",\"author\":{\"@id\":\"https:\/\/brakkeconsulting.com\/ja\/#\/schema\/person\/cbd3330707aa1f20925a2f9d78722615\"},\"breadcrumb\":{\"@id\":\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-july-29-2022\/#breadcrumb\"},\"inLanguage\":\"ja\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-july-29-2022\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/brakkeconsulting.com\/brakke-viewpoint-july-29-2022\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/brakkeconsulting.com\/ja\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Brakke Viewpoint July 29, 2022\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/brakkeconsulting.com\/ja\/#website\",\"url\":\"https:\/\/brakkeconsulting.com\/ja\/\",\"name\":\"Brakke Consulting Website\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/brakkeconsulting.com\/ja\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"ja\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/brakkeconsulting.com\/ja\/#\/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-july-29-2022\/","og_locale":"ja_JP","og_type":"article","og_title":"News from Brakke Consulting","og_description":"Do high FDA Animal Drug Users Fees slow innovation in animal drugs? Each year the FDA ADUFA\/AGDUFA fees change due to inflation, workload, and prior year excesses or shortfalls in collections.\u00a0 Starting in October, New Animal Drug Applications will require a $659,364 check and a supplemental application will need a $329,682 check, 13.5% more than last year.\u00a0 A generic drug ANADA will need a $494,983 check in 2023, down from $548,628 in 2022 due primarily to excess collections in 2021.\u00a0 That\u2019s a lot of money and it must impact innovation. 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