{"id":9620,"date":"2026-03-11T14:41:45","date_gmt":"2026-03-11T06:41:45","guid":{"rendered":"https:\/\/regask.com\/?p=9620"},"modified":"2026-03-11T15:50:07","modified_gmt":"2026-03-11T07:50:07","slug":"fda%e3%81%af%e3%80%81%e6%96%b0%e8%96%ac%e6%89%bf%e8%aa%8d%e7%94%b3%e8%ab%8b%ef%bc%88nda%ef%bc%89%e3%81%8a%e3%82%88%e3%81%b3%e3%82%b5%e3%83%97%e3%83%aa%e3%83%a1%e3%83%b3%e3%83%88%e3%81%ae3%e5%b9%b4","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/","title":{"rendered":"FDA\u30013\u5e74\u9593\u306e\u81e8\u5e8a\u6295\u8cc7\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u8349\u6848\u3092\u767a\u8868"},"content":{"rendered":"<p><span data-contrast=\"auto\">\u306e\u4e0a\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e743\u67084\u65e5<\/span><\/b><span data-contrast=\"auto\">\u3001\u00a0<\/span><b><span data-contrast=\"auto\">\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09<\/span><\/b><span data-contrast=\"auto\">\u00a0\u51fa\u7248\u3057\u305f\u00a0<\/span><b><span data-contrast=\"auto\">\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u6848<\/span><\/b><span data-contrast=\"auto\">\u00a0\u30a2\u30c9\u30ec\u30c3\u30b7\u30f3\u30b0\u00a0<\/span><b><span data-contrast=\"auto\">3\u5e74\u9593\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u72ec\u5360\u6a29<\/span><\/b><span data-contrast=\"auto\">\u00a0\u533b\u85ac\u54c1\u306b\u3064\u3044\u3066\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001\u72ec\u5360\u6a29\u3092\u6c42\u3081\u308b\u7533\u8acb\u8005\u306b\u5bfe\u3059\u308b\u898f\u5236\u4e0a\u306e\u671f\u5f85\u3092\u660e\u78ba\u306b\u3057\u3066\u3044\u308b\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u65b0\u85ac\u7533\u8acb\uff08NDA\uff09<\/span><\/b><span data-contrast=\"auto\">\u00a0\u305d\u3057\u3066\u00a0<\/span><b><span data-contrast=\"auto\">NDA\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8<\/span><\/b><span data-contrast=\"auto\">, \u7279\u306b\u3001\u65b0\u305f\u306a\u81e8\u5e8a\u8abf\u67fb\u304c\u3053\u308c\u3089\u306e\u63d0\u51fa\u3092\u88cf\u4ed8\u3051\u308b\u5834\u5408\u306b\u306f\u3001\u305d\u3046\u3057\u307e\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6848\u306f\u3001\u7533\u8acb\u8005\u304c\u00a0<\/span><b><span data-contrast=\"auto\">\u6cd5\u5b9a\u304a\u3088\u3073\u898f\u5236\u4e0a\u306e\u9069\u683c\u57fa\u6e96<\/span><\/b><span data-contrast=\"auto\">\u00a0\u53d6\u5f97\u306b\u5fc5\u8981\u306a\u00a0<\/span><b><span data-contrast=\"auto\">3\u5e74\u9593\u306e\u72ec\u5360\u6a29<\/span><\/b><span data-contrast=\"auto\">. \u307e\u305f\u3001\u4ee5\u4e0b\u306e\u70b9\u306b\u95a2\u3059\u308b\u63a8\u5968\u4e8b\u9805\u3082\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u72ec\u5360\u6a29\u30ea\u30af\u30a8\u30b9\u30c8\u306e\u5185\u5bb9\u3068\u5f62\u5f0f<\/span><\/b><span data-contrast=\"auto\">, \u69cb\u9020\u5316\u3055\u308c\u305f\u00a0<\/span><b><span data-contrast=\"auto\">\u8cea\u7591\u5fdc\u7b54\u5f62\u5f0f<\/span><\/b><span data-contrast=\"auto\">. \u3053\u306e\u6587\u66f8\u306f\u73fe\u5728\u3001\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u3092\u53d7\u3051\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e745\u67084\u65e5<\/span><\/b><span data-contrast=\"auto\">, \u305d\u306e\u5f8c\u3001FDA \u306f\u5229\u5bb3\u95a2\u4fc2\u8005\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u691c\u8a0e\u3057\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u6700\u7d42\u6c7a\u5b9a\u3057\u307e\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-573395127\">\n\n\t<div id=\"col-1686485955\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1800823627\" class=\"gap-element clearfix\" style=\"display:block; 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FDA\u306f\u3001\u5fc5\u8981\u306a\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3068\u88dc\u8db3\u60c5\u5831\u306b\u95a2\u3059\u308b\u671f\u5f85\u3092\u660e\u78ba\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u7533\u8acb\u8005\u304c\u72ec\u5360\u6a29\u7533\u8acb\u3092\u63d0\u51fa\u3059\u308b\u65b9\u6cd5\u306e\u4e00\u8cab\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u3055\u3089\u306b\u3001\u540c\u5e81\u306f\u3001\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u4eca\u5f8c\u3082\u9032\u5316\u3057\u7d9a\u3051\u308b\u3060\u308d\u3046\u3068\u6307\u6458\u3057\u3066\u3044\u308b\u3002.\u00a0<\/span><b><span 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id=\"gap-1929360905\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1929360905 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">\u5229\u5bb3\u95a2\u4fc2\u8005\u306f\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u63d0\u51fa\u3059\u308b<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u00a0\u30b3\u30e1\u30f3\u30c8\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">FDA\u306e\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u306b\u95a2\u3057\u3066<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\"> 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\u65b0\u305f\u306a\u81e8\u5e8a\u8abf\u67fb\u306b\u3088\u3063\u3066\u88cf\u4ed8\u3051\u3089\u308c\u305f NDA \u3084\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3092\u6e96\u5099\u3059\u308b\u30b9\u30dd\u30f3\u30b5\u30fc\u306e\u4e0d\u78ba\u5b9f\u6027\u3092\u8efd\u6e1b\u3057\u307e\u3059\u3002.<\/span><\/span><span class=\"EOP SCXW213098303 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-299156182 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-66025746\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u8ab0\u306b\u95a2\u4fc2\u304c\u3042\u308b\u304b<\/h2>\n\t<div id=\"gap-469761045\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-469761045 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u7279\u306b\u3001\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">\u88fd\u85ac\u30e1\u30fc\u30ab\u30fc\u3001\u6cbb\u9a13\u30b9\u30dd\u30f3\u30b5\u30fc\u3001\u85ac\u4e8b\u95a2\u9023\u696d\u52d9\u30c1\u30fc\u30e0\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u5c02\u9580\u5bb6<\/span><\/span><\/strong><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">\u00a0\u6e96\u5099\u3092\u62c5\u5f53\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\"><strong>\u81e8\u5e8a\u8a66\u9a13\u3067\u88cf\u4ed8\u3051\u3089\u308c\u305fNDA\u7533\u8acb\u307e\u305f\u306f\u88dc\u8db3\u8cc7\u6599<\/strong><\/span><\/span><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\"><strong>.<\/strong> \u7c73\u56fd\u306b\u304a\u3051\u308b\u533b\u85ac\u54c1\u958b\u767a\u304a\u3088\u3073\u5e02\u5834\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u4e0e\u3059\u308b\u7d44\u7e54\u306f\u3001\u72ec\u5360\u6a29\u8981\u6c42\u3078\u306e\u5f71\u97ff\u3092\u7406\u89e3\u3059\u308b\u305f\u3081\u306b\u30ac\u30a4\u30c0\u30f3\u30b9\u8349\u6848\u3092\u691c\u8a0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/span><\/span><span class=\"EOP SCXW4282818 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-66025746 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-835094091\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/h2>\n\t<div id=\"gap-1580748975\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1580748975 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u898f\u5236\u5f53\u5c40\u306f\u3001\u00a0<\/span><b><span data-contrast=\"auto\">3\u5e74\u9593\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u72ec\u5360\u6a29\u306b\u95a2\u3059\u308bFDA\u30ac\u30a4\u30c0\u30f3\u30b9\u6848<\/span><\/b><span data-contrast=\"auto\">\u00a0\u305d\u3057\u3066\u305d\u308c\u304c\u3069\u306e\u3088\u3046\u306b\u5f71\u97ff\u3059\u308b\u304b\u3092\u8a55\u4fa1\u3059\u308b\u00a0<\/span><b><span data-contrast=\"auto\">\u73fe\u5728\u307e\u305f\u306f\u8a08\u753b\u4e2d\u306eNDA\u304a\u3088\u3073NDA\u88dc\u8db3\u7533\u8acb<\/span><\/b><span data-contrast=\"auto\">. \u95a2\u4fc2\u8005\u306f\u3001\u4f1a\u8b70\u524d\u306b\u63d0\u51fa\u3059\u308b\u30b3\u30e1\u30f3\u30c8\u3001\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3001\u307e\u305f\u306f\u660e\u78ba\u5316\u306e\u305f\u3081\u306e\u8cea\u554f\u3092\u6e96\u5099\u3059\u308b\u3053\u3068\u3082\u691c\u8a0e\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e745\u67084\u65e5 \u30b3\u30e1\u30f3\u30c8\u7de0\u3081\u5207\u308a<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u8907\u6570\u306e\u5e02\u5834\u306b\u308f\u305f\u308b\u8907\u6570\u306e\u898f\u5236\u7533\u8acb\u3092\u7ba1\u7406\u3059\u308b\u7d44\u7e54\u306f\u3001\u9032\u5316\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3084\u7533\u8acb\u306e\u671f\u5f85\u3092\u8ffd\u8de1\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u96c6\u4e2d\u578b\u306e\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9 \u30c4\u30fc\u30eb\u306e\u30e1\u30ea\u30c3\u30c8\u3082\u4eab\u53d7\u3067\u304d\u307e\u3059\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a>\u00a0\u306f\u4e00\u6d41\u306e\u00a0<\/span><b><span data-contrast=\"auto\">\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8\u578bAI\u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u304a\u3088\u3073\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/span><\/b><span data-contrast=\"auto\">\u00a0\u6d88\u8cbb\u8ca1\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306a\u3069\u3001\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u3092\u7a4d\u6975\u7684\u306b\u4e57\u308a\u8d8a\u3048\u3089\u308c\u308b\u3088\u3046\u652f\u63f4\u3057\u307e\u3059\u3002\u9ad8\u5ea6\u306a\u00a0<\/span><b><span data-contrast=\"auto\">\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5c02\u9580\u5bb6\u306e\u5354\u529b\u3092\u5f97\u3066\u3001,\u00a0<a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a>\u00a0\u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u4e88\u6e2c\u7684\u304b\u3064\u5b9f\u7528\u7684\u306a\u6d1e\u5bdf\u3068\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u81ea\u52d5\u5316\u3092\u63d0\u4f9b\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001100\u4ee5\u4e0a\u306e\u5e02\u5834\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3057\u307e\u3059\u3002\u00a0<\/span><b><span data-contrast=\"auto\">160\u30ab\u56fd<\/span><\/b><span data-contrast=\"auto\">. <a href=\"http:\/\/regask.com\/ja\/\"><strong>\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b <\/strong><\/a>\u307e\u305f\u306f<a href=\"https:\/\/regask.com\/ja\/%e3%83%87%e3%83%a2%e3%82%92%e4%ba%88%e7%b4%84%e3%81%99%e3%82%8b\/\"><strong> \u4eca\u3059\u3050\u30c7\u30e2\u3092\u4e88\u7d04\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-835094091 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1044095057\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/h2>\n\t<div id=\"gap-1919851289\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1919851289 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u5bb3\u95a2\u4fc2\u8005\u306f\u3001 <strong>FDA\u4e73\u5150\u7528\u8abf\u88fd\u7c89\u4e73\u306e\u30a6\u30a7\u30d6\u30ea\u30bd\u30fc\u30b9\u3092\u66f4\u65b0\u3057\u307e\u3057\u305f<\/strong> \u305d\u3057\u3066\u65b0\u305f\u306b <strong>\u516c\u958b\u5e02\u5834\u30ea\u30b9\u30c8<\/strong> \u793e\u5185\u8a18\u9332\u3068\u516c\u958b\u3055\u308c\u308b\u88fd\u54c1\u60c5\u5831\u304c\u6574\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>\n<p>\u898f\u5236\u3001\u54c1\u8cea\u3001\u55b6\u696d\u30c1\u30fc\u30e0\u306f\u3001 <strong>\u88fd\u54c1\u30ea\u30b9\u30c8\u3068\u4f1a\u793e\u60c5\u5831\u304c\u6b63\u78ba\u306b\u53cd\u6620\u3055\u308c\u3066\u3044\u308b<\/strong> \u516c\u958b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3067\u516c\u958b\u3055\u308c\u3066\u3044\u308b\u3002\u7d44\u7e54\u306f\u3001\u4eca\u5f8c\u306e\u900f\u660e\u6027\u5411\u4e0a\u306e\u305f\u3081\u306e\u53d6\u308a\u7d44\u307f\u3092\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3059\u308b\u3053\u3068\u3082\u691c\u8a0e\u3067\u304d\u308b\u3002 <strong>\u30b9\u30c8\u30fc\u30af\u30b9\u30d4\u30fc\u30c9\u4f5c\u6226<\/strong> \u6f5c\u5728\u7684\u306a\u653f\u7b56\u306e\u5c55\u958b\u3084\u898f\u5236\u63aa\u7f6e\u306b\u3064\u3044\u3066\u306e\u60c5\u5831\u3092\u5165\u624b\u3059\u308b\u305f\u3081\u3002.<\/p>\n<p>\u898f\u5236\u306e\u900f\u660e\u6027\u306b\u95a2\u3059\u308b\u53d6\u308a\u7d44\u307f\u304c\u9032\u5316\u3057\u7d9a\u3051\u308b\u306b\u3064\u308c\u3066\u3001\u4e16\u754c\u7684\u306a\u898f\u5236\u306e\u66f4\u65b0\u306b\u95a2\u3059\u308b\u53ef\u8996\u6027\u3092\u7dad\u6301\u3059\u308b\u3053\u3068\u304c\u307e\u3059\u307e\u3059\u91cd\u8981\u306b\u306a\u308a\u307e\u3059\u3002. <a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u7d44\u7e54\u304c\u898f\u5236\u306e\u52d5\u5411\u3092\u76e3\u8996\u3057\u3001\u8907\u6570\u306e\u7ba1\u8f44\u533a\u57df\u306b\u308f\u305f\u308b\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7ba1\u7406\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n<p><a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u306f\u3001\u6d88\u8cbb\u8ca1\u3084\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u306a\u3069\u306e\u898f\u5236\u306e\u53b3\u3057\u3044\u5206\u91ce\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u7d44\u7e54\u304c\u8907\u96d1\u306a\u898f\u5236\u74b0\u5883\u306b\u7a4d\u6975\u7684\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3001\u4e3b\u8981\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8 AI \u898f\u5236\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u304a\u3088\u3073\u30ef\u30fc\u30af\u30d5\u30ed\u30fc \u30aa\u30fc\u30b1\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3 \u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002. <strong>\u9ad8\u5ea6\u306a\u30a8\u30fc\u30b8\u30a7\u30f3\u30c8AI\u3068\u5c02\u9580\u5bb6\u306e\u5354\u529b\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u3067\u3001, <a href=\"http:\/\/regask.com\/ja\/\">RegASK<\/a><\/strong> \u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u4e88\u6e2c\u7684\u304b\u3064\u5b9f\u7528\u7684\u306a\u6d1e\u5bdf\u3068\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u81ea\u52d5\u5316\u3092\u63d0\u4f9b\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001160 \u304b\u56fd\u4ee5\u4e0a\u3067\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3057\u307e\u3059\u3002. <a href=\"http:\/\/regask.com\/ja\/\"><strong>\u3082\u3063\u3068\u8a73\u3057\u304f\u77e5\u308b <\/strong><\/a>\u307e\u305f\u306f<strong><a href=\"https:\/\/regask.com\/ja\/%e3%83%87%e3%83%a2%e3%82%92%e4%ba%88%e7%b4%84%e3%81%99%e3%82%8b\/\"> \u4eca\u3059\u3050\u30c7\u30e2\u3092\u4e88\u7d04\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/a>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1044095057 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-538543976\">\n\n\t<div id=\"col-1771211070\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h3>\n\t<div id=\"gap-1822298751\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1822298751 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW99703309 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW99703309 BCX0\" data-ccp-parastyle=\"heading 3\">3 \u5e74\u9593\u306e\u81e8\u5e8a\u7814\u7a76\u306e\u72ec\u5360\u6a29\u306b\u95a2\u3059\u308b FDA \u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u8349\u6848\u3068\u306f\u4f55\u3067\u3059\u304b?<\/span><\/span><span class=\"EOP SCXW99703309 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-776946903\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-776946903 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u306e\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">FDA\u306f3\u67084\u65e5\u306b\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c\u3057\u305f\u3002,\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW263241192 BCX0\">2026<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>\u00a0<\/strong>\u5fdc\u52df\u8005\u306b\u63a8\u85a6\u72b6\u3092\u63d0\u4f9b\u3059\u308b<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">3\u5e74\u9593\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u72ec\u5360\u6a29<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0\u306e\u305f\u3081\u306b\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u65b0\u85ac\u7533\u8acb\uff08NDA\uff09<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u307e\u305f\u306f<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">NDA\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>.<\/strong>\u00a0<\/span><span class=\"NormalTextRun SCXW263241192 BCX0\">\u305d\u308c\u306f\u3001\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u8cc7\u683c\u57fa\u6e96<\/span><\/span><\/strong><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\"><strong>\u00a0<\/strong>\u305d\u3057\u3066\u3001\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u5185\u5bb9\u3068\u5f62\u5f0f<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0\u72ec\u5360\u6a29\u306e\u30ea\u30af\u30a8\u30b9\u30c8\u306b\u671f\u5f85\u3055\u308c\u307e\u3059\u3002.<\/span><\/span><span class=\"EOP SCXW263241192 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1771211070 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1114944108\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW114531365 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW114531365 BCX0\" data-ccp-parastyle=\"heading 3\">3 \u5e74\u9593\u306e\u81e8\u5e8a\u7814\u7a76\u306e\u72ec\u5360\u6a29\u3092\u7533\u8acb\u3067\u304d\u308b\u306e\u306f\u8ab0\u3067\u3059\u304b?<\/span><\/span><span class=\"EOP SCXW114531365 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-435149798\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-435149798 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">\u5fdc\u52df\u8005\u00a0<\/span><span class=\"NormalTextRun SCXW124616724 BCX0\">\u63d0\u51fa<\/span><span class=\"NormalTextRun SCXW124616724 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">\u65b0\u305f\u306a\u81e8\u5e8a\u8abf\u67fb\u306b\u3088\u3063\u3066\u88cf\u4ed8\u3051\u3089\u308c\u305f\u30aa\u30ea\u30b8\u30ca\u30eb\u306eNDA\u307e\u305f\u306fNDA\u88dc\u8db3<\/span><\/span><\/strong><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">\u00a0\u30ea\u30af\u30a8\u30b9\u30c8\u3059\u308b\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">3\u5e74\u9593\u306e\u72ec\u5360\u6a29<\/span><\/span><\/strong><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\"><strong>,<\/strong> \u305f\u3060\u3057\u3001FDA \u304c\u5b9a\u3081\u308b\u6cd5\u5b9a\u304a\u3088\u3073\u898f\u5236\u4e0a\u306e\u9069\u683c\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u6761\u4ef6\u3068\u306a\u308a\u307e\u3059\u3002.<\/span><\/span><span class=\"EOP SCXW124616724 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1114944108 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1319753268\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW110399116 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">\u7de0\u3081\u5207\u308a\u306f\u3044\u3064\u3067\u3059\u304b\uff1f\u00a0<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">\u63d0\u51fa\u3059\u308b<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0FDA \u306e\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3064\u3044\u3066\u30b3\u30e1\u30f3\u30c8\u306f\u3042\u308a\u307e\u3059\u304b?<\/span><\/span><span class=\"EOP SCXW110399116 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-975510897\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-975510897 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">\u5229\u5bb3\u95a2\u4fc2\u8005\u306f\u00a0<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">\u63d0\u51fa\u3059\u308b<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">\u00a0\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">\u30c9\u30e9\u30d5\u30c8\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><\/span><\/strong><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">\u305d\u308c\u307e\u3067<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">2026\u5e745\u67084\u65e5<\/span><\/span><\/strong><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\"><strong>,<\/strong> FDA\u306e\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">\u30aa\u30f3\u30e9\u30a4\u30f3\u307e\u305f\u306f\u66f8\u9762\u306b\u3088\u308b\u63d0\u51fa\u30c1\u30e3\u30cd\u30eb<\/span><\/span><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">.<\/span><\/span><span class=\"EOP SCXW109329519 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1319753268 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-650209241\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>RegASK \u306f\u3001GMO \u30e9\u30d9\u30eb\u8981\u4ef6\u3092\u7ba1\u7406\u3059\u308b\u4f01\u696d\u3092\u3069\u306e\u3088\u3046\u306b\u30b5\u30dd\u30fc\u30c8\u3067\u304d\u307e\u3059\u304b?<\/h4>\n\t<div id=\"gap-443562436\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-443562436 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><a href=\"http:\/\/regask.com\/ja\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW19024172 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0\u63d0\u4f9b\u3059\u308b\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">AI\u3092\u6d3b\u7528\u3057\u305f\u898f\u5236\u60c5\u5831\u3068\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u81ea\u52d5\u5316<\/span><\/span><\/strong><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0\u7d44\u7e54\u304c\u00a0<\/span><span class=\"NormalTextRun SCXW19024172 BCX0\">\u30e2\u30cb\u30bf\u30fc<\/span><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 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