{"id":5685,"date":"2019-06-17T14:07:46","date_gmt":"2019-06-17T14:07:46","guid":{"rendered":"https:\/\/blog.kolabtree.com\/?p=5685"},"modified":"2020-03-06T07:13:10","modified_gmt":"2020-03-06T07:13:10","slug":"how-to-get-fda-approval-4-expert-tips","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-fda-approval-4-expert-tips\/","title":{"rendered":"FDA\u306e\u627f\u8a8d\u3092\u5f97\u308b\u306b\u306f\u3069\u3046\u3059\u308c\u3070\u3088\u3044\u304b\u3002\u5c02\u9580\u5bb6\u306b\u3088\u308b4\u3064\u306e\u30d2\u30f3\u30c8"},"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\">table of contents<\/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-69f1a70728802\" 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-69f1a70728802\"><\/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\/ja\/how-to-get-fda-approval-4-expert-tips\/#1_Organise_your_paperwork\" title=\"1.\u66f8\u985e\u306e\u6574\u7406\">1.\u66f8\u985e\u306e\u6574\u7406<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-fda-approval-4-expert-tips\/#2_Present_measurable_evidence\" title=\"2.\u6e2c\u5b9a\u53ef\u80fd\u306a\u8a3c\u62e0\u306e\u63d0\u793a\">2.\u6e2c\u5b9a\u53ef\u80fd\u306a\u8a3c\u62e0\u306e\u63d0\u793a<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-fda-approval-4-expert-tips\/#3_Keep_a_thorough_record\" title=\"3.\u5fb9\u5e95\u3057\u305f\u8a18\u9332\u3092\u6b8b\u3059\">3.\u5fb9\u5e95\u3057\u305f\u8a18\u9332\u3092\u6b8b\u3059<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-fda-approval-4-expert-tips\/#4_Final_considerations\" title=\"4.\u6700\u7d42\u7684\u306a\u691c\u8a0e\u4e8b\u9805\">4.\u6700\u7d42\u7684\u306a\u691c\u8a0e\u4e8b\u9805<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>\u3053\u306e\u8a18\u4e8b\u3067\u306fDr.Harneet Arora\u3092\u7d39\u4ecb\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/harneet_arora-pt\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u30fb\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30b5\u30a4\u30a8\u30f3\u30c6\u30a3\u30b9\u30c8<\/a>t on Kolabtree\u306e\u30e1\u30f3\u30d0\u30fc\u3067\u3042\u308a\u3001FDA\u898f\u5236\u306e\u5c02\u9580\u5bb6\u3067\u3082\u3042\u308b\u5f7c\u5973\u304c\u3001\u30a2\u30e1\u30ea\u30ab\u3067\u65b0\u85ac\u306eFDA\u627f\u8a8d\u3092\u5f97\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u30a2\u30c9\u30d0\u30a4\u30b9\u3092\u3057\u3066\u3044\u307e\u3059\u3002\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\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> and development to labelling and final release on the market, is strictly monitored by the Food and Drug Administration (FDA). However, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert?search=fda&amp;utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">FDA\u3078\u306e\u7533\u8acb<\/a> \u65b0\u85ac\u306e\u958b\u767a\u306f\u3001\u307e\u3055\u306b\u5730\u96f7\u539f\u306e\u3088\u3046\u306a\u3082\u306e\u3067\u3059\u3002<\/p>\n<p><strong>\u30de\u30b5\u30c1\u30e5\u30fc\u30bb\u30c3\u30c4\u5de5\u79d1\u5927\u5b66\u306e\u6700\u8fd1\u306e\u7814\u7a76\u306b\u3088\u308b\u3068\u3001\u516c\u8846\u885b\u751f\u306e\u4fdd\u8b77\u3068\u4fc3\u9032\u3092\u62c5\u5f53\u3059\u308b\u7c73\u56fd\u306e\u9023\u90a6\u6a5f\u95a2\u3067\u3042\u308bFDA\u304b\u3089\u627f\u8a8d\u3092\u5f97\u3089\u308c\u308b\u306e\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u4e2d\u306e\u5168\u533b\u85ac\u54c1\u306e\u3046\u3061\u7d0414%\u306b\u904e\u304e\u307e\u305b\u3093\u3002\u3064\u307e\u308a\u3001\u63d0\u6848\u3055\u308c\u305f\u65b0\u85ac\u306e\u3046\u306186%\u304c\u3001\u5546\u54c1\u5316\u307e\u3067\u306e\u904e\u7a0b\u3067\u4f55\u304b\u554f\u984c\u304c\u767a\u751f\u3057\u3001\u6642\u9593\u3001\u30a8\u30cd\u30eb\u30ae\u30fc\u3001\u8cc7\u672c\u3092\u6d6a\u8cbb\u3057\u3066\u3044\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/strong><\/p>\n<p>\u3067\u306f\u3001FDA\u627f\u8a8d\u7533\u8acb\u6642\u306b\u907f\u3051\u3089\u308c\u308b\u30df\u30b9\u306b\u306f\u3069\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u3001\u7533\u8acb\u8005\u306f\u305d\u308c\u3092\u9632\u3050\u305f\u3081\u306b\u4f55\u3092\u3059\u308c\u3070\u3088\u3044\u306e\u3067\u3057\u3087\u3046\u304b\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Organise_your_paperwork\"><\/span>1.\u66f8\u985e\u306e\u6574\u7406<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6700\u521d\u306e\u9593\u9055\u3044\u306f\u3001\u6700\u3082\u7c21\u5358\u306b\u56de\u907f\u3067\u304d\u308b\u3082\u306e\u3067\u3059\u304c\u3001\u4e0d\u5b8c\u5168\u306a\u7533\u8acb\u66f8\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3067\u3059\u3002FDA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3066\u3001\u5fc5\u8981\u306a\u30d5\u30a9\u30fc\u30e0\u304c\u3059\u3079\u3066\u63d0\u51fa\u3055\u308c\u3066\u3044\u308b\u304b\u3001\u307e\u305f\u305d\u308c\u3089\u304c\u5b8c\u5168\u306b\u8a18\u5165\u3055\u308c\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <strong>\u6cbb\u9a13\u85ac\uff08IND\uff09\u7533\u8acb\u306e\u91cd\u8981\u66f8\u985e\u306e\u4e00\u3064\u3067\u3042\u308b1572\u30d5\u30a9\u30fc\u30e0\u306b\u8a18\u5165\u3059\u308b\u969b\u306b\u306f\u3001\u7279\u306b\u6ce8\u610f\u304c\u5fc5\u8981\u3067\u3059\u3002<\/strong><\/p>\n<p>1572\u30d5\u30a9\u30fc\u30e0\u306f\u3001\u7533\u8acb\u8005\u304c\u504f\u898b\u3084\u5229\u76ca\u76f8\u53cd\u3092\u6301\u3063\u3066\u3044\u306a\u3044\u3053\u3068\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u95a2\u3059\u308bFDA Code of Federal Regulations\u306b\u5f93\u3046\u3053\u3068\u306b\u540c\u610f\u3057\u3066\u3044\u308b\u3053\u3068\u3001\u502b\u7406\u7684\u304b\u3064\u79d1\u5b66\u7684\u306b\u53b3\u5bc6\u306a\u65b9\u6cd5\u3067\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u7d4c\u9a13\u3092\u6301\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u30d5\u30a9\u30fc\u30e0\u306e\u30a8\u30e9\u30fc\u3092\u907f\u3051\u308b\u3053\u3068\u3067\u3001\u5f8c\u3005\u306e\u4fdd\u7559\u3092\u9632\u3050\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Present_measurable_evidence\"><\/span>2.\u6e2c\u5b9a\u53ef\u80fd\u306a\u8a3c\u62e0\u306e\u63d0\u793a<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306e\u3059\u3079\u3066\u306e\u6bb5\u968e\u304c\u7d42\u4e86\u3059\u308b\u3068\u3001FDA\u306f\u305d\u306e\u7d50\u679c\u3092\u691c\u8a0e\u3057\u3001\u516c\u958b\u8a0e\u8ad6\u4f1a\uff08\u591a\u304f\u306e\u5834\u5408\u3001\u30d0\u30fc\u30c1\u30e3\u30eb\uff09\u3092\u958b\u50ac\u3057\u3066\u3001\u88fd\u85ac\u4f01\u696d\u304c\u81ea\u793e\u306e\u63d0\u6848\u3059\u308b\u533b\u85ac\u54c1\u304c\u6709\u52b9\u3067\u3042\u308a\u3001\u540c\u3058\u75c5\u6c17\u306b\u5bfe\u3059\u308b\u65e2\u5b58\u306e\u533b\u85ac\u54c1\u3088\u308a\u3082\u5927\u304d\u306a\u5229\u70b9\u304c\u3042\u308b\u3068\u3044\u3046\u8a3c\u62e0\u3092\u63d0\u793a\u3057\u307e\u3059\u3002\u3053\u3053\u3067\u306e\u76ee\u7684\u306f\u3001\u65b0\u85ac\u304c\u5b89\u5168\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u306f\u306a\u304f\u3001\u60a3\u8005\u3055\u3093\u306e\u751f\u6d3b\u3092\u5927\u304d\u304f\u6539\u5584\u3059\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u3053\u3068\u3067\u3059\uff08\u3053\u308c\u306fin vitro\u304a\u3088\u3073in vivo\u306e\u7814\u7a76\u3067\u3059\u3067\u306b\u6c7a\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\uff09\u3002<\/p>\n<p>\u79c1\u306e\u7d4c\u9a13\u3067\u306f\u3001\u3053\u306e\u6bb5\u968e\u3067\u5374\u4e0b\u3055\u308c\u308b\u3053\u3068\u304c\u591a\u3044\u306e\u3067\u3059\u304c\u3001\u305d\u306e\u7406\u7531\u306f\u3001\u305d\u306e\u85ac\u306e\u6709\u52b9\u6027\u3084\u3001\u3059\u3067\u306b\u5e02\u8ca9\u3055\u308c\u3066\u3044\u308b\u6cbb\u7642\u6cd5\u3088\u308a\u3082\u512a\u308c\u3066\u3044\u308b\u70b9\u306b\u3064\u3044\u3066\u306e\u660e\u78ba\u306a\u30c7\u30fc\u30bf\u304c\u306a\u3044\u305f\u3081\u3067\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u85ac\u306e\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u6e2c\u5b9a\u53ef\u80fd\u306a\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u63d0\u793a\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<strong> \u4f8b\u3048\u3070\u3001\u300c2%\u3067\u60a3\u8005\u3055\u3093\u306e\u75c7\u72b6\u304c\u6539\u5584\u3057\u305f\u300d\u3068\u3044\u3046\u3060\u3051\u3067\u306f\u4e0d\u5341\u5206\u3067\u3001\u305d\u306e\u6539\u5584\u306e\u5185\u5bb9\u3092\u660e\u793a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/strong><\/p>\n<p>\u307e\u305f\u3001\u524d\u8a18\u306e\u6539\u5584\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u53c2\u8003\u8cc7\u6599\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3082\u91cd\u8981\u3067\u3059\u3002\u65b0\u85ac\u3092\u670d\u7528\u3057\u3066\u3044\u308b\u60a3\u8005\u3055\u3093\u3068\u30d7\u30e9\u30bb\u30dc\u3092\u670d\u7528\u3057\u3066\u3044\u308b\u5bfe\u7167\u7fa4\u3068\u306e\u6bd4\u8f03\u3084\u3001\u65e2\u306b\u767a\u58f2\u3055\u308c\u3066\u3044\u308b\u85ac\u3092\u670d\u7528\u3057\u3066\u3044\u308b\u60a3\u8005\u3055\u3093\u3068\u306e\u6bd4\u8f03\u306a\u3069\u304c\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Keep_a_thorough_record\"><\/span>3.\u5fb9\u5e95\u3057\u305f\u8a18\u9332\u3092\u6b8b\u3059<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u65b0\u85ac\u306e\u958b\u767a\u30fb\u8a66\u9a13\u306b\u304a\u3044\u3066\u306f\u3001in vitro\u3084\u52d5\u7269\u5b9f\u9a13\u306e\u6b63\u78ba\u306a\u524d\u81e8\u5e8a\u30c7\u30fc\u30bf\u304b\u3089\u3001\u63a8\u5968\u3055\u308c\u308b\u521d\u671f\u7528\u91cf\u3084\u6700\u5927\u7528\u91cf\u304c\u3069\u306e\u3088\u3046\u306b\u8a2d\u5b9a\u3055\u308c\u305f\u304b\u307e\u3067\u3001\u3059\u3079\u3066\u306e\u6bb5\u968e\u3092\u9069\u5207\u306b\u8a18\u9332\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u307e\u305f\u3001\u7533\u8acb\u8005\u306f\u3001\u5341\u5206\u306a\u6570\u306e\u88ab\u9a13\u8005\u3092\u5bfe\u8c61\u3068\u3057\u305f\u8a66\u9a13\u304c\u884c\u308f\u308c\u305f\u3053\u3068\u3092\u8a3c\u660e\u3057\u3001\u305d\u306e\u6cbb\u7642\u306b\u5bfe\u3059\u308b\u88ab\u9a13\u8005\u306e\u53cd\u5fdc\u3092\u6ce8\u610f\u6df1\u304f\u8a18\u9332\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u7279\u306b\u3001\u7533\u8acb\u8005\u306f\u88ab\u9a13\u8005\u304c\u7d4c\u9a13\u3057\u305f\u6709\u5bb3\u306a\u526f\u4f5c\u7528\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u88ab\u9a13\u8005\u306e\u4e00\u90e8\u304c\u8a66\u9a13\u304b\u3089\u8131\u843d\u3057\u305f\u5834\u5408\u306f\u3001\u305d\u306e\u7406\u7531\u3092\u8aac\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>\u307e\u305f\u3001\u65b0\u85ac\u306e\u5229\u70b9\u304c\u526f\u4f5c\u7528\u3092\u4e0a\u56de\u308a\u3001\u305d\u306e\u526f\u4f5c\u7528\u306e\u7a0b\u5ea6\u304c\u540c\u3058\u75c5\u6c17\u3067\u65e2\u306b\u5e02\u8ca9\u3055\u308c\u3066\u3044\u308b\u85ac\u3088\u308a\u3082\u8efd\u3044\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u5614\u5410\u3084\u504f\u982d\u75db\u3092\u5f15\u304d\u8d77\u3053\u3059\u672b\u671f\u75be\u60a3\u306e\u6cbb\u7642\u85ac\u3067\u3042\u3063\u3066\u3082\u3001\u60a3\u8005\u3055\u3093\u306e\u5bff\u547d\u3092\u5927\u5e45\u306b\u5ef6\u3070\u3059\u3053\u3068\u304c\u3067\u304d\u308c\u3070\u627f\u8a8d\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u4e00\u65b9\u3001\u9ad8\u8840\u5727\u75c7\u306e\u6cbb\u7642\u85ac\u306b\u540c\u3058\u526f\u4f5c\u7528\u304c\u5831\u544a\u3055\u308c\u305f\u5834\u5408\u306f\u3001\u3088\u308a\u526f\u4f5c\u7528\u306e\u5c11\u306a\u3044\u6cbb\u7642\u85ac\u304c\u3059\u3067\u306b\u5e02\u8ca9\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u627f\u8a8d\u3055\u308c\u306a\u3044\u53ef\u80fd\u6027\u304c\u9ad8\u3044\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/p>\n<p><strong>\u3044\u305a\u308c\u306b\u3057\u3066\u3082\u3001\u7533\u8acb\u8005\u306f\u30ea\u30b9\u30af\u8a55\u4fa1\u304a\u3088\u3073\u7de9\u548c\u6226\u7565\uff08REMS\uff09\u3092\u63d0\u793a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u305a\u3001\u305d\u3053\u3067\u306f\u6700\u7d42\u7684\u306a\u526f\u4f5c\u7528\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b\u3069\u306e\u3088\u3046\u306a\u5bfe\u7b56\u3092\u8b1b\u3058\u308b\u304b\u3092\u8a73\u7d30\u306b\u8aac\u660e\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/strong> \u4f8b\u3048\u3070\u3001\u6cbb\u7642\u3092\u53d7\u3051\u308b\u969b\u306b\u907f\u598a\u304c\u5fc5\u8981\u304b\u3069\u3046\u304b\u3001\u5fc5\u8981\u3067\u3042\u308c\u3070\u3069\u306e\u3088\u3046\u306a\u907f\u598a\u3092\u3059\u308b\u306e\u304b\u306a\u3069\u3001\u526f\u4f5c\u7528\u3092\u907f\u3051\u308b\u305f\u3081\u306b\u60a3\u8005\u3055\u3093\u304c\u3059\u3079\u304d\u3053\u3068\u3092\u3067\u304d\u308b\u3060\u3051\u5177\u4f53\u7684\u306b\u8a18\u8f09\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Final_considerations\"><\/span>4.\u6700\u7d42\u7684\u306a\u691c\u8a0e\u4e8b\u9805<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>\u65b0\u85ac\u304c\u627f\u8a8d\u3055\u308c\u308b\u305f\u3081\u306b\u306f\u3001\u8a66\u9a13\u306b\u53c2\u52a0\u3057\u305f\u88ab\u9a13\u8005\u306e\u5c11\u306a\u304f\u3068\u308280%\u304c\u6539\u5584\u306e\u5146\u5019\u3092\u793a\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/strong> \u3053\u308c\u3089\u306e\u8a3c\u62e0\u304c\u6b63\u3057\u304f\u63d0\u793a\u3055\u308c\u3001\u30b5\u30f3\u30d7\u30eb\u30b0\u30eb\u30fc\u30d7\u304c\u6709\u610f\u306a\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3059\u308b\u306e\u306b\u5341\u5206\u306a\u5927\u304d\u3055\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u3001\u7533\u8acb\u8005\u306f\u5c02\u9580\u306e\u7d71\u8a08\u5b66\u8005\u306e\u652f\u63f4\u3092\u5fc5\u8981\u3068\u3059\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3053\u306e\u6bb5\u968e\u3067\u306f\u3001\u793e\u5185\u306b\u7d71\u8a08\u5b66\u8005\u304c\u3044\u306a\u3044\u4f01\u696d\u306f\u3001\u30b5\u30f3\u30d7\u30eb\u30b0\u30eb\u30fc\u30d7\u306e\u9078\u629e\u3084\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u30fb\u5206\u6790\u3092\u652f\u63f4\u3057\u3066\u304f\u308c\u308b\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u5b66\u8005\u3068\u306e\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u3092\u691c\u8a0e\u3059\u3079\u304d\u3067\u3057\u3087\u3046\u3002<\/p>\n<p>\u6700\u5f8c\u306b\u3001FDA\u306f\u3044\u3064\u3067\u3082\u3001\u533b\u85ac\u54c1\u306e\u958b\u767a\u30fb\u8a66\u9a13\u3092\u884c\u3063\u3066\u3044\u308b\u65bd\u8a2d\u304cGCP\uff08Good Clinical Practice\uff09\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u76e3\u67fb\u3067\u304d\u308b\u3053\u3068\u3092\u899a\u3048\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001FDA\u306f\u76e3\u67fb\u306e\u969b\u306b\u3001\u3059\u3079\u3066\u306e\u62c5\u5f53\u8005\u304c\u5b89\u5168\u306b\u696d\u52d9\u3092\u9042\u884c\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u8cc7\u683c\u3092\u6301\u3063\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>FDA\u3078\u306e\u627f\u8a8d\u7533\u8acb\u306f\u7dca\u5f35\u3059\u308b\u3082\u306e\u3067\u3059\u304c\u3001FDA\u306e\u624b\u7d9a\u304d\u3092\u719f\u77e5\u3057\u305f\u5c02\u9580\u5bb6\u306b\u76f8\u8ac7\u3059\u308b\u3053\u3068\u3067\u3001\u30d7\u30ed\u30bb\u30b9\u3092\u30b9\u30e0\u30fc\u30ba\u306b\u9032\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u88fd\u85ac\u4f1a\u793e\u306e\u4e2d\u306b\u306f\u3001\u305d\u306e\u305f\u3081\u306e\u898f\u5236\u90e8\u9580\u3092\u793e\u5185\u306b\u8a2d\u7f6e\u3057\u3066\u3044\u308b\u3068\u3053\u308d\u3082\u3042\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u304c\u3001\u4e2d\u5c0f\u4f01\u696d\u3067\u306f\u305d\u306e\u3088\u3046\u306a\u6295\u8cc7\u3092\u3059\u308b\u3060\u3051\u306e\u80fd\u529b\u3084\u4e88\u7b97\u304c\u306a\u3044\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u305d\u306e\u3088\u3046\u306a\u5834\u5408\u306f\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u5c02\u9580\u5bb6\u3092\u96c7\u3046\u3053\u3068\u3067\u89e3\u6c7a\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><strong>\u6709\u8cc7\u683c\u8005\u306b\u76f8\u8ac7 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert?search=fda&amp;utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">FDA\u7533\u8acb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u3092Kolabtree\u306b\u767b\u9332\u3059\u308b\u3053\u3068\u3067\u3001\u85ac\u304c\u627f\u8a8d\u3055\u308c\u308b\u53ef\u80fd\u6027\u3092\u9ad8\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u30a2\u30af\u30bb\u30b9 <a href=\"https:\/\/www.kolabtree.com\/services\/clinical-research-consulting?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u81e8\u5e8a\u7814\u7a76\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u30b5\u30fc\u30d3\u30b9<\/a> \u4e16\u754c\u4e2d\u306e\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u304b\u3089\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3057\u3066\u898b\u7a4d\u3082\u308a\u3092\u3082\u3089\u3046\u306e\u306f\u7121\u6599\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/create-project?search=fda&amp;utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u3042\u306a\u305f\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u4eca\u3059\u3050\u6295\u7a3f<\/a>.<\/strong><\/p>\n<p><strong>\u95a2\u9023\u3059\u308b\u5c02\u9580\u5bb6\u00a0<\/strong><\/p>\n<p><a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Bioinformatics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u30d0\u30a4\u30aa\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9\u30fb\u30d5\u30ea\u30fc\u30e9\u30f3\u30b5\u30fc<\/a>\u00a0|\u00a0<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Plant-Genetics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u690d\u7269\u907a\u4f1d\u5b66<\/a>\u00a0|\u00a0<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Developmental-Biology?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u767a\u751f\u751f\u7269\u5b66<\/a>\u00a0|\u00a0<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Gene-Therapy?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u907a\u4f1d\u5b50\u6cbb\u7642<\/a>\u00a0|\u00a0<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Stem-Cells?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u5e79\u7d30\u80de\u00a0<\/a>|<br \/>\n<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/DNA-Sequencing-Data-Analysis?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">DNA\u30b7\u30fc\u30af\u30a8\u30f3\u30b9\u30c7\u30fc\u30bf\u306e\u89e3\u6790<\/a>\u00a0|<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Animal-Genetics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u52d5\u7269\u907a\u4f1d\u5b66<\/a>\u00a0|<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/Drug-Interactions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u00a0\u85ac\u7269\u76f8\u4e92\u4f5c\u7528<\/a>\u00a0|\u00a0<a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/genetics-and-genomics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDAApproval\">\u907a\u4f1d\u5b66\u30fb\u30b2\u30ce\u30df\u30af\u30b9\u00a0<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001Kolabtree\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u81e8\u5e8a\u79d1\u5b66\u8005\u3067\u3042\u308a\u3001FDA\u898f\u5236\u306e\u5c02\u9580\u5bb6\u3067\u3042\u308bHarneet Arora\u535a\u58eb\u304c\u3001\u7c73\u56fd\u3067\u65b0\u85ac\u306eFDA\u627f\u8a8d\u3092\u5f97\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u30a2\u30c9\u30d0\u30a4\u30b9\u3092\u3057\u3066\u3044\u307e\u3059\u3002  \u7c73\u56fd\u3067\u306e\u65b0\u85ac\u306e\u5546\u696d\u5316\u306f\u3001\u53b3\u683c\u306a\u9053\u7b4b\u306b\u6cbf\u3063\u3066\u884c\u308f\u308c\u307e\u3059\u3002\u7814\u7a76\u958b\u767a\u304b\u3089\u30e9\u30d9\u30eb\u8868\u793a\u3001\u6700\u7d42\u7684\u306a\u5e02\u5834\u3078\u306e\u30ea\u30ea\u30fc\u30b9\u307e\u3067\u306e\u5404\u30b9\u30c6\u30c3\u30d7\u306f\u3001FDA\uff08Food and Drug Administration\uff09\u306b\u3088\u3063\u3066\u53b3\u3057\u304f\u76e3\u8996\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001FDA\u306b\u65b0\u85ac\u306e\u627f\u8a8d\u3092\u7533\u8acb\u3059\u308b\u3053\u3068\u306f\u3001\u975e\u5e38\u306b\u56f0\u96e3\u306a\u3053\u3068\u3067\u3059\u3002\u30de\u30b5\u30c1\u30e5\u30fc\u30bb\u30c3\u30c4\u5de5\u79d1\u5927\u5b66\u306e\u6700\u8fd1\u306e\u7814\u7a76\u306b\u3088\u308b\u3068\u3001\u81e8\u5e8a\u8a66\u9a13\u4e2d\u306e\u533b\u85ac\u54c1\u306e\u3046\u3061\u3001FDA\u306e\u627f\u8a8d\u3092\u5f97\u3089\u308c\u308b\u306e\u306f14%\u7a0b\u5ea6\u3060\u305d\u3046\u3067\u3059\u3002<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-fda-approval-4-expert-tips\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":5687,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,304,247,443],"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 to get FDA approval: 4 expert tips - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Freelance clinical scientist and FDA applications consultant Dr. Harneet Arora shares her tips on how to improve your chances of getting your drug approved\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-get-fda-approval-4-expert-tips\/\" \/>\n<meta property=\"og:locale\" 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