{"id":9589,"date":"2026-03-03T22:23:32","date_gmt":"2026-03-03T14:23:32","guid":{"rendered":"https:\/\/regask.com\/?p=9589"},"modified":"2026-03-03T22:23:32","modified_gmt":"2026-03-03T14:23:32","slug":"fda%e3%81%af%e3%82%b8%e3%82%a7%e3%83%8d%e3%83%aa%e3%83%83%e3%82%af%e5%8c%bb%e8%96%ac%e5%93%81%e3%81%ae%e9%96%8b%e7%99%ba%e3%81%a8anda%e6%89%bf%e8%aa%8d%e3%82%92%e6%94%af%e6%8f%b4%e3%81%99%e3%82%8b","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/fda-issues-draft-product-specific-guidances-to-support-generic-drug-development-and-anda-approvals\/","title":{"rendered":"FDA \u304c\u88fd\u54c1\u5225\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u8349\u6848\u3092\u767a\u884c\u3057\u3001\u2026 \u3092\u30b5\u30dd\u30fc\u30c8"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2026\u5e742\u670826\u65e5, <\/strong>\u305d\u306e<strong> \u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001\u4e00\u9023\u306e\u88fd\u54c1\u5225\u30ac\u30a4\u30c0\u30f3\u30b9\uff08PSG\uff09\u306e\u8349\u6848\u3092\u516c\u958b\u3057\u305f\u3002<\/strong> \u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u958b\u767a\u3068\u5408\u7406\u5316\u3092\u652f\u63f4\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f <strong>\u7c21\u7565\u65b0\u85ac\u7533\u8acb\uff08ANDA\uff09<\/strong> \u533b\u85ac\u54c1\u306e\u627f\u8a8d\u3002\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001ANDA\u306e\u958b\u767a\u3001\u7533\u8acb\u3001\u5be9\u67fb\u306b\u95a2\u308f\u308b\u4f01\u696d\u3084\u30c1\u30fc\u30e0\u3001\u7279\u306b\u4ee5\u4e0b\u306e\u5206\u91ce\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3057\u307e\u3059\u3002 <strong>\u8907\u96d1\u306a\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u88fd\u54c1\u3068\u8907\u96d1\u3067\u306a\u3044\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u88fd\u54c1\u3002. <\/strong><\/p>\n<div class=\"row\"  id=\"row-2092917277\">\n\n\t<div id=\"col-1553079520\" 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-1179064651\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1179064651 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u8a73\u7d30<\/h2>\n\t<div id=\"gap-293275801\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-293275801 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>FDA\u306f\u3001\u4ee5\u4e0b\u306e\u3053\u3068\u3092\u5b9f\u8a3c\u3059\u308b\u305f\u3081\u306e\u898f\u5236\u4e0a\u306e\u671f\u5f85\u3092\u6982\u8aac\u3057\u305f\u65b0\u3057\u3044PSG\u8349\u6848\u3068\u6539\u8a02\u7248PSG\u8349\u6848\u3092\u767a\u8868\u3057\u305f\u3002 <strong>\u6cbb\u7642\u7684\u540c\u7b49\u6027<\/strong> \u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u533b\u85ac\u54c1\u3092\u53c2\u7167\u3059\u308b\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u3001 <strong>\u73fe\u5728\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306f\u306a\u3044\u3002,<\/strong> \u65b0\u305f\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u5c0e\u5165\u3059\u308b <strong>\u30aa\u30d4\u30aa\u30a4\u30c9\u4f7f\u7528\u969c\u5bb3\u306e\u6cbb\u7642 <\/strong>\u305d\u3057\u3066<strong> \u5fc3\u8840\u7ba1\u30ea\u30b9\u30af\u4f4e\u6e1b\u306e\u305f\u3081\u306e\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u3002.\u00a0<\/strong><\/p>\n<p>\u3044\u304f\u3064\u304b\u306e\u65e2\u5b58\u306ePSG\u304c\u6539\u8a02\u3055\u308c\u3001\u66f4\u65b0\u306b\u3088\u308a <strong>\u653e\u51fa\u8abf\u7bc0\u88fd\u5264\u304a\u3088\u3073\u7d4c\u76ae\u304a\u3088\u3073\u5c40\u6240\u30b7\u30b9\u30c6\u30e0\u3001,<\/strong> \u305d\u306e\u7d50\u679c\u3001\u7814\u7a76\u306e\u671f\u5f85\u5024\u306b\u6b21\u306e\u3088\u3046\u306a\u5909\u5316\u304c\u751f\u3058\u308b\u3002<strong> \u30a2\u30eb\u30b3\u30fc\u30eb\u6295\u4e0e\u91cf\u30c0\u30f3\u30d4\u30f3\u30b0\u7814\u7a76 <\/strong>\u305d\u3057\u3066<strong> \u611f\u4f5c\u30c6\u30b9\u30c8\u3002.<\/strong> \u3055\u3089\u306b\u3001FDA\u306f\u30aa\u30f3\u30e9\u30a4\u30f3\u30ea\u30b9\u30c8\u3092\u66f4\u65b0\u3057\u3001 <strong>\u958b\u767a\u4e2d\u306ePSG\u3001,<\/strong> \u958b\u767a\u8a08\u753b\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u3001\u4e88\u60f3\u3055\u308c\u308b\u516c\u958b\u65e5\u3082\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1553079520 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-670048523\" 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>\u306a\u305c\u305d\u308c\u304c\u91cd\u8981\u306a\u306e\u304b<\/h2>\n\t<div id=\"gap-2125184999\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2125184999 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u308c\u3089\u306e\u30c9\u30e9\u30d5\u30c8PSG\u306f\u3088\u308a\u5927\u304d\u306a <strong>\u898f\u5236\u306e\u660e\u78ba\u3055<\/strong> \u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u958b\u767a\u306e\u305f\u3081\u306e\u7814\u7a76\u30c7\u30b6\u30a4\u30f3\u3068\u30c7\u30fc\u30bf\u8981\u4ef6\u306b\u95a2\u3059\u308b\u30b5\u30dd\u30fc\u30c8 <strong>\u30c7\u30b8\u30bf\u30eb\u8abf\u6574\u3068\u8a08\u753b\u306e\u52b9\u7387<\/strong> ANDA\u30d7\u30ed\u30b0\u30e9\u30e0\u5411\u3051\u3002\u8907\u96d1\u306a\u88fd\u54c1\u3068\u8907\u96d1\u3067\u306a\u3044\u88fd\u54c1\u306e\u4e21\u65b9\u306b\u304a\u3051\u308b\u671f\u5f85\u3092\u660e\u78ba\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u4e88\u6e2c\u53ef\u80fd\u6027\u3092\u5411\u4e0a\u3055\u305b\u3064\u3064\u3001 <strong>\u4e2d\u7acb\u7684\u306a\u5f71\u97ff\u3068\u6700\u5c0f\u9650\u306e\u8ffd\u52a0\u898f\u5236\u8ca0\u62c5<\/strong> \u696d\u754c\u95a2\u4fc2\u8005\u5411\u3051\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-670048523 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1517097777\" 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-950513952\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-950513952 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u3001 <strong>\u898f\u5236\u696d\u52d9\u3001\u54c1\u8cea\u4fdd\u8a3c\u3001\u7814\u7a76\u958b\u767a\u3001, <\/strong>\u305d\u3057\u3066<strong> \u6cd5\u52d9\u30c1\u30fc\u30e0<\/strong> \u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u958b\u767a\u3084 ANDA \u7533\u8acb\u306b\u643a\u308f\u308b\u65b9\u3001\u7279\u306b\u8907\u96d1\u306a\u51e6\u65b9\u3084\u7814\u7a76\u8981\u4ef6\u304c\u5909\u5316\u3059\u308b\u88fd\u54c1\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u308b\u65b9\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1517097777 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1477969025\" 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-440816734\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-440816734 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4f01\u696d\u306f <strong>\u73fe\u5728\u304a\u3088\u3073\u8a08\u753b\u4e2d\u306eANDA\u7533\u8acb\u3092\u8a55\u4fa1\u3059\u308b<\/strong> \u65b0\u305f\u306b\u516c\u958b\u307e\u305f\u306f\u6539\u8a02\u3055\u308c\u305fPSG\u3068\u7167\u5408\u3057\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3084\u30c7\u30fc\u30bf\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u30ae\u30e3\u30c3\u30d7\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u304c\u5f71\u97ff\u3092\u53d7\u3051\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u5834\u5408\u3001\u7533\u8acb\u8005\u306f <strong>FDA\u3068\u306e\u96fb\u8a71\u4f1a\u8b70\u3092\u8981\u8acb\u3059\u308b <\/strong>\u4e0b<strong> GDUFA III \u306e\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u3002.<\/strong> \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306b\u95a2\u9023\u3059\u308b\u5c06\u6765\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u4e88\u6e2c\u3059\u308b\u305f\u3081\u306b\u3001FDA \u306e PSG \u30ea\u30b9\u30c8\u3092\u7d99\u7d9a\u7684\u306b\u76e3\u8996\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002.<\/p>\n<p>\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306b\u5bfe\u3059\u308b\u898f\u5236\u4e0a\u306e\u671f\u5f85\u306f\u9032\u5316\u3057\u7d9a\u3051\u3066\u3044\u308b\u305f\u3081\u3001\u8349\u6848\u304a\u3088\u3073\u4eca\u5f8c\u306e PSG \u3092\u5148\u53d6\u308a\u3059\u308b\u3053\u3068\u306f\u3001\u52b9\u7387\u7684\u306a\u958b\u767a\u8a08\u753b\u3092\u7acb\u3066\u308b\u305f\u3081\u306b\u91cd\u8981\u3067\u3059\u3002. <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,<\/strong> <a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \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\u30c1\u30fc\u30e0\u304c FDA \u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u66f4\u65b0\u3092\u8ffd\u8de1\u3057\u3001ANDA \u30d7\u30ed\u30b0\u30e9\u30e0\u3078\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001160 \u304b\u56fd\u4ee5\u4e0a\u3067\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u5408\u7406\u5316\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002. <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\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1477969025 > .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-397337452\">\n\n\t<div id=\"col-1795182814\" 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-1966898289\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1966898289 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW45210204 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45210204 BCX0\">\u4f55\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed GrammarErrorHighlight SCXW45210204 BCX0\">\u306f<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0FDA\u88fd\u54c1\u5225\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW45210204 BCX0\">\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0\uff08PSG\uff09\uff1f<\/span><\/span><span class=\"EOP SCXW45210204 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1817249334\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1817249334 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>FDA PSG \u306f\u3001\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u7533\u8acb\u306b\u304a\u3051\u308b\u6cbb\u7642\u4e0a\u306e\u540c\u7b49\u6027\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306e\u63a8\u5968\u7814\u7a76\u8a2d\u8a08\u3068\u30c7\u30fc\u30bf\u8981\u4ef6\u3092\u6982\u8aac\u3057\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3067\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1795182814 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-207842323\" 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 SCXW266917646 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266917646 BCX0\">2026 \u5e74 2 \u6708\u306e PSG \u30c9\u30e9\u30d5\u30c8\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067\u306f\u3044\u304f\u3064\u306e\u88fd\u54c1\u304c\u30ab\u30d0\u30fc\u3055\u308c\u3066\u3044\u307e\u3059\u304b?<\/span><\/span><span class=\"EOP SCXW266917646 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-724788926\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-724788926 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">FDA\u306e\u8349\u6848\u3067\u306f\u3001\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">98 \u88fd\u54c1<\/span><\/span><span class=\"TextRun SCXW195383774 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW195383774 BCX0\">, \u65b0\u898f\u304a\u3088\u3073\u6539\u8a02\u7248\u3092\u542b\u3080\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW195383774 BCX0\">\u30ac\u30a4\u30c0\u30f3\u30b9<\/span><span class=\"NormalTextRun SCXW195383774 BCX0\">.<\/span><\/span><span class=\"EOP SCXW195383774 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-207842323 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-112458871\" 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 SCXW234189171 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234189171 BCX0\">\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306b\u3088\u3063\u3066\u6700\u3082\u5f71\u97ff\u3092\u53d7\u3051\u308b\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306e\u7a2e\u985e\u306f\u4f55\u3067\u3059\u304b?<\/span><\/span><span class=\"EOP SCXW234189171 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-587545141\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-587545141 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306f\u7279\u306b <strong>\u8907\u5408\u88fd\u54c1\u3001\u5f90\u653e\u6027\u88fd\u5264\u3001\u7d4c\u76ae\u304a\u3088\u3073\u5c40\u6240\u30b7\u30b9\u30c6\u30e0\u3001,<\/strong> \u3060\u3051\u3067\u306a\u304f\u3001 <strong>\u30aa\u30d4\u30aa\u30a4\u30c9\u4f7f\u7528\u969c\u5bb3\u3068\u7d4c\u53e3\u30bb\u30de\u30b0\u30eb\u30c1\u30c9\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-112458871 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1778081588\" 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 SCXW39904085 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW39904085 BCX0\">\u3069\u3046\u3059\u308c\u3070\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW39904085 BCX0\">RegASK<\/span><span class=\"NormalTextRun SCXW39904085 BCX0\">\u00a0\u30c1\u30fc\u30e0\u304c FDA PSG \u306e\u66f4\u65b0\u3092\u7ba1\u7406\u3067\u304d\u308b\u3088\u3046\u306b\u652f\u63f4\u3057\u307e\u3059\u304b?<\/span><\/span><span class=\"EOP SCXW39904085 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1097385440\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1097385440 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><a href=\"http:\/\/regask.com\/ja\/\"><strong>RegASK<\/strong><\/a> \u898f\u5236\u304a\u3088\u3073\u958b\u767a\u30c1\u30fc\u30e0\u304c\u8349\u6848\u304a\u3088\u3073\u6700\u7d42\u7684\u306a PSG \u3092\u8ffd\u8de1\u3057\u3001\u9032\u884c\u4e2d\u306e ANDA \u30d7\u30ed\u30b0\u30e9\u30e0\u3078\u306e\u5f71\u97ff\u3092\u8a55\u4fa1\u3057\u3001\u5c02\u9580\u5bb6\u306b\u3088\u3063\u3066\u30b5\u30dd\u30fc\u30c8\u3055\u308c\u308b AI \u4e3b\u5c0e\u306e\u6d1e\u5bdf\u3092\u4f7f\u7528\u3057\u3066\u898f\u5236\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u8abf\u6574\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1778081588 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On February 26, 2026, the U.S. Food and Drug Administration (FDA) published a batch of draft product-specific guidances (PSGs) aimed at supporting generic drug development and streamlining Abbreviated New Drug Application (ANDA) approvals for pharmaceuticals. The update affects companies and teams involved in developing, submitting, or reviewing ANDAs, particularly for both complex and non-complex generic products.<\/p>","protected":false},"author":41,"featured_media":9590,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,35],"tags":[],"class_list":["post-9589","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-pharma-biotech-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Issues Draft Product-Specific Guidances Overview<\/title>\n<meta name=\"description\" content=\"Explore the FDA issues regarding product-specific guidances to support generic drug development and ANDA approvals 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