{"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%e5%8f%91%e5%b8%83%e5%85%b3%e4%ba%8e%e6%96%b0%e8%8d%af%e7%94%b3%e8%af%b7%e5%92%8c%e8%a1%a5%e5%85%85%e7%94%b3%e8%af%b7%e4%b8%89%e5%b9%b4%e4%b8%b4%e5%ba%8a%e7%a0%94%e7%a9%b6%e7%8b%ac%e5%8d%a0","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/","title":{"rendered":"FDA\u53d1\u5e03\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u6307\u5357\u8349\u6848\u2026\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">\u5728\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e743\u67084\u65e5<\/span><\/b><span data-contrast=\"auto\">\uff0c \u8fd9\u00a0<\/span><b><span data-contrast=\"auto\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40 (FDA)<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5df2\u53d1\u5e03\u00a0<\/span><b><span data-contrast=\"auto\">\u6307\u5bfc\u6587\u4ef6\u8349\u6848<\/span><\/b><span data-contrast=\"auto\">\u00a0\u89e3\u51b3\u00a0<\/span><b><span data-contrast=\"auto\">\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\u6743<\/span><\/b><span data-contrast=\"auto\">\u00a0\u9488\u5bf9\u836f\u54c1\u3002\u8be5\u6307\u5357\u660e\u786e\u4e86\u7533\u8bf7\u72ec\u5360\u6743\u7684\u7533\u8bf7\u4eba\u6240\u5e94\u9075\u5b88\u7684\u76d1\u7ba1\u8981\u6c42\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u65b0\u836f\u7533\u8bf7\uff08NDA\uff09<\/span><\/b><span data-contrast=\"auto\">\u00a0\u548c\u00a0<\/span><b><span data-contrast=\"auto\">NDA\u8865\u5145\u5242<\/span><\/b><span data-contrast=\"auto\">, \u5c24\u5176\u662f\u5f53\u65b0\u7684\u4e34\u5e8a\u7814\u7a76\u652f\u6301\u8fd9\u4e9b\u7533\u8bf7\u65f6\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\">\u8be5\u6307\u5bfc\u8349\u6848\u65e8\u5728\u5e2e\u52a9\u7533\u8bf7\u4eba\u7406\u89e3\u2026\u2026\u00a0<\/span><b><span data-contrast=\"auto\">\u6cd5\u5b9a\u548c\u76d1\u7ba1\u8d44\u683c\u6807\u51c6<\/span><\/b><span data-contrast=\"auto\">\u00a0\u9700\u8981\u83b7\u5f97\u00a0<\/span><b><span data-contrast=\"auto\">\u4e09\u5e74\u72ec\u5bb6\u4ee3\u7406\u6743<\/span><\/b><span data-contrast=\"auto\">. \u5b83\u8fd8\u5c31\u4ee5\u4e0b\u65b9\u9762\u63d0\u4f9b\u5efa\u8bae\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u72ec\u5bb6\u6388\u6743\u8bf7\u6c42\u7684\u5185\u5bb9\u548c\u683c\u5f0f<\/span><\/b><span data-contrast=\"auto\">, \u4ee5\u7ed3\u6784\u5316\u7684\u65b9\u5f0f\u5448\u73b0\u00a0<\/span><b><span data-contrast=\"auto\">\u95ee\u7b54\u5f62\u5f0f<\/span><\/b><span data-contrast=\"auto\">. \u8be5\u6587\u4ef6\u76ee\u524d\u6b63\u516c\u5f00\u5f81\u6c42\u516c\u4f17\u610f\u89c1\uff0c\u76f4\u81f3\u2026\u2026\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e745\u67084\u65e5<\/span><\/b><span data-contrast=\"auto\">, \u4e4b\u540e\uff0cFDA\u5c06\u5ba1\u67e5\u5229\u76ca\u76f8\u5173\u8005\u7684\u53cd\u9988\u610f\u89c1\uff0c\u7136\u540e\u518d\u6700\u7ec8\u786e\u5b9a\u8be5\u6307\u5357\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-407769021\">\n\n\t<div id=\"col-292906047\" 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-789094017\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-789094017 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-1868586617\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1868586617 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u8be5\u6307\u5bfc\u8349\u6848\u6982\u8ff0\u4e86\u00a0<\/span><b><span data-contrast=\"auto\">\u6587\u6863\u6807\u51c6<\/span><\/b><span data-contrast=\"auto\">\u00a0\u7533\u8bf7\u4eba\u7533\u8bf7\u65f6\u5e94\u9075\u5faa\u7684\u89c4\u5219\u00a0<\/span><b><span data-contrast=\"auto\">\u4e3a\u671f\u4e09\u5e74\u7684\u72ec\u5bb6\u4e34\u5e8a\u7814\u7a76<\/span><\/b><span data-contrast=\"auto\">. \u5b83\u5c31\u5982\u4f55\u63d0\u4ea4\u4fdd\u5bc6\u534f\u8bae\u6216\u4fdd\u5bc6\u534f\u8bae\u8865\u5145\u6587\u4ef6\u4ee5\u652f\u6301\u72ec\u5bb6\u8bb8\u53ef\u8bf7\u6c42\u6240\u9700\u7684\u4fe1\u606f\u63d0\u4f9b\u4e86\u8be6\u7ec6\u7684\u5efa\u8bae\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\">\u8be5\u6307\u5357\u9002\u7528\u4e8e\u4e24\u8005\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u539f\u59cb\u4fdd\u5bc6\u534f\u8bae<\/span><\/b><span data-contrast=\"auto\">\u00a0\u548c\u00a0<\/span><b><span data-contrast=\"auto\">NDA\u8865\u5145\u5242<\/span><\/b><span data-contrast=\"auto\">\u00a0\u4f9d\u8d56\u4e8e\u00a0<\/span><b><span data-contrast=\"auto\">\u65b0\u7684\u4e34\u5e8a\u7814\u7a76<\/span><\/b><span data-contrast=\"auto\">. \u901a\u8fc7\u660e\u786e\u5bf9\u683c\u5f0f\u548c\u6240\u9700\u652f\u6301\u4fe1\u606f\u7684\u8981\u6c42\uff0cFDA \u65e8\u5728\u63d0\u9ad8\u7533\u8bf7\u4eba\u63d0\u4ea4\u72ec\u5360\u6743\u7533\u8bf7\u7684\u4e00\u81f4\u6027\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\">\u6b64\u5916\uff0c\u8be5\u673a\u6784\u6307\u51fa\uff0c\u76f8\u5173\u6307\u5bfc\u610f\u89c1\u5c06\u4e0d\u65ad\u66f4\u65b0\u5b8c\u5584\u3002.\u00a0<\/span><b><span data-contrast=\"auto\">\u672a\u6765\u7684\u66f4\u65b0\u53ef\u80fd\u4f1a\u5305\u542b\u66f4\u591a\u95ee\u9898\u548c\u7b54\u6848\u3002<\/span><\/b><span data-contrast=\"auto\">\u00a0\u968f\u7740\u65b0\u7684\u76d1\u7ba1\u5f62\u52bf\u51fa\u73b0\uff0c\u4ee5\u53ca\u5229\u76ca\u76f8\u5173\u8005\u7684\u53cd\u9988\u610f\u89c1\u88ab\u7eb3\u5165\u8003\u91cf\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\t\t<\/div>\n\t\t\t\t\n<style>\n#col-292906047 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-623238108\" 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>\u53cd\u9988\u622a\u6b62\u65e5\u671f<\/h2>\n\t<div id=\"gap-2054571723\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2054571723 {\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\u76ca\u76f8\u5173\u8005\u53ef\u80fd\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u63d0\u4ea4<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u00a0\u8bc4\u8bba\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 \u6307\u5357\u8349\u6848\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u5173\u4e8e<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\"> \u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\u6743\u00a0<\/span><\/span><\/strong><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">\u76f4\u5230 <\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">2026\u5e745\u67084\u65e5<\/span><\/span><\/strong><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\"><strong>.<\/strong> \u8bc4\u8bba\u53ef\u4ee5\u662f\u00a0<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u63d0\u4ea4<\/span><span class=\"NormalTextRun SCXW57646166 BCX0\">\u00a0\u901a\u8fc7FDA\u7684\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\">\u5728\u7ebf\u6216\u4e66\u9762\u63d0\u4ea4\u6e20\u9053<\/span><\/span><span class=\"TextRun SCXW57646166 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW57646166 BCX0\">.<\/span><\/span><span class=\"EOP SCXW57646166 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-623238108 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1244858944\" 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>\u4e3a\u4ec0\u4e48\u91cd\u8981<\/h2>\n\t<div id=\"gap-1603002902\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1603002902 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u8be5\u6307\u5bfc\u8349\u6848\u63d0\u4f9b\u4e86\u66f4\u5927\u7684\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u76d1\u7ba1\u900f\u660e\u5ea6<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u00a0\u5173\u4e8e\u8d44\u683c\u548c\u6587\u4ef6\u8981\u6c42\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u4e09\u5e74\u6570\u636e\u72ec\u5360\u6743<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u00a0\u4e0e\u7f8e\u56fd\u836f\u54c1\u5ba1\u6279\u76f8\u5173\u7684\u4e8b\u9879\u3002\u66f4\u6e05\u6670\u7684\u9884\u671f\u6709\u52a9\u4e8e\u7b80\u5316\u7533\u62a5\u51c6\u5907\u5de5\u4f5c\uff0c\u5e76\u63d0\u4f9b\u652f\u6301\u3002<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\">\u76d1\u7ba1\u4e00\u81f4\u6027<\/span><\/span><\/strong><span class=\"TextRun SCXW213098303 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW213098303 BCX0\"><strong>,<\/strong> \u5e76\u964d\u4f4e\u8d5e\u52a9\u5546\u51c6\u5907\u65b0\u836f\u7533\u8bf7\u6216\u8865\u5145\u7533\u8bf7\uff08\u7531\u65b0\u7684\u4e34\u5e8a\u7814\u7a76\u652f\u6301\uff09\u65f6\u7684\u4e0d\u786e\u5b9a\u6027\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-1244858944 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1998582746\" 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>\u8fd9\u9002\u7528\u4e8e\u54ea\u4e9b\u4eba\u7fa4<\/h2>\n\t<div id=\"gap-2051772556\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2051772556 {\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\">\u6b64\u66f4\u65b0\u5c24\u5176\u9002\u7528\u4e8e\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\">\u5236\u836f\u4f01\u4e1a\u3001\u4e34\u5e8a\u7533\u529e\u65b9\u3001\u6cd5\u89c4\u4e8b\u52a1\u56e2\u961f\u548c\u5408\u89c4\u4e13\u4e1a\u4eba\u5458<\/span><\/span><\/strong><span class=\"TextRun SCXW4282818 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW4282818 BCX0\">\u00a0\u8d1f\u8d23\u51c6\u5907\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>\u4e34\u5e8a\u7814\u7a76\u652f\u6301\u7684NDA\u7533\u8bf7\u6216\u8865\u5145\u7533\u8bf7<\/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> \u53c2\u4e0e\u7f8e\u56fd\u836f\u7269\u7814\u53d1\u548c\u5e02\u573a\u51c6\u5165\u6d41\u7a0b\u7684\u7ec4\u7ec7\u5e94\u5ba1\u9605\u8be5\u6307\u5bfc\u8349\u6848\uff0c\u4ee5\u4e86\u89e3\u5176\u5bf9\u72ec\u5360\u6743\u7533\u8bf7\u7684\u5f71\u54cd\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-1998582746 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-182004770\" 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>\u4e0b\u4e00\u6b65<\/h2>\n\t<div id=\"gap-2029628887\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2029628887 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u76d1\u7ba1\u56e2\u961f\u5e94\u5ba1\u67e5\u00a0<\/span><b><span data-contrast=\"auto\">FDA\u5173\u4e8e\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\u6743\u7684\u6307\u5bfc\u8349\u6848<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5e76\u8bc4\u4f30\u5176\u53ef\u80fd\u4ea7\u751f\u7684\u5f71\u54cd\u00a0<\/span><b><span data-contrast=\"auto\">\u5f53\u524d\u6216\u8ba1\u5212\u63d0\u4ea4\u7684NDA\u548cNDA\u8865\u5145\u7533\u8bf7<\/span><\/b><span data-contrast=\"auto\">. \u5229\u76ca\u76f8\u5173\u8005\u8fd8\u53ef\u4ee5\u8003\u8651\u5728\u4f1a\u8bae\u53ec\u5f00\u524d\u51c6\u5907\u8bc4\u8bba\u3001\u53cd\u9988\u6216\u6f84\u6e05\u95ee\u9898\u3002\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e745\u67084\u65e5\u610f\u89c1\u5f81\u96c6\u622a\u6b62\u65e5\u671f<\/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\">\u5bf9\u4e8e\u9700\u8981\u8de8\u5e02\u573a\u7ba1\u7406\u591a\u4e2a\u76d1\u7ba1\u7533\u62a5\u7684\u673a\u6784\u800c\u8a00\uff0c\u96c6\u4e2d\u5f0f\u76d1\u7ba1\u60c5\u62a5\u5de5\u5177\u4e5f\u80fd\u5e2e\u52a9\u5176\u8ddf\u8e2a\u4e0d\u65ad\u53d8\u5316\u7684\u6307\u5bfc\u610f\u89c1\u548c\u7533\u62a5\u8981\u6c42\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\/zh\/\"><strong>RegASK<\/strong><\/a>\u00a0\u662f\u9886\u5148\u7684\u00a0<\/span><b><span data-contrast=\"auto\">agentic AI \u76d1\u7ba1\u667a\u80fd\u548c\u5de5\u4f5c\u6d41\u7a0b\u7f16\u6392\u5e73\u53f0<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5b83\u8d4b\u80fd\u5168\u7403\u4f01\u4e1a\uff0c\u4f7f\u5176\u80fd\u591f\u79ef\u6781\u5e94\u5bf9\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\u5728\u5185\u7684\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u590d\u6742\u76d1\u7ba1\u73af\u5883\u3002\u901a\u8fc7\u7ed3\u5408\u5148\u8fdb\u7684\u6280\u672f\uff0c\u00a0<\/span><b><span data-contrast=\"auto\">\u4ee3\u7406\u4eba\u5de5\u667a\u80fd<\/span><\/b><span data-contrast=\"auto\">\u00a0\u6709\u4e13\u5bb6\u53c2\u4e0e\u5176\u4e2d\uff0c,\u00a0<a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a>\u00a0\u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u4e14\u53ef\u64cd\u4f5c\u7684\u6d1e\u5bdf\u548c\u7aef\u5230\u7aef\u81ea\u52a8\u5316\uff0c\u7b80\u5316\u5408\u89c4\u6d41\u7a0b\uff0c\u964d\u4f4e\u98ce\u9669\uff0c\u5e76\u52a0\u901f\u5e02\u573a\u51c6\u5165\uff0c\u8986\u76d6\u8d85\u8fc7\u00a0<\/span><b><span data-contrast=\"auto\">160\u4e2a\u56fd\u5bb6<\/span><\/b><span data-contrast=\"auto\">. <a href=\"http:\/\/regask.com\/zh\/\"><strong>\u4e86\u89e3\u66f4\u591a <\/strong><\/a>\u6216\u8005<a href=\"https:\/\/regask.com\/zh\/%e9%a2%84%e8%ae%a2%e6%bc%94%e7%a4%ba\/\"><strong> \u7acb\u5373\u9884\u8ba2\u6f14\u793a\u3002<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-182004770 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1433083344\" 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>\u4e0b\u4e00\u6b65<\/h2>\n\t<div id=\"gap-952308538\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-952308538 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u76ca\u76f8\u5173\u8005\u5e94\u5ba1\u67e5 <strong>\u66f4\u65b0\u540e\u7684FDA\u5a74\u513f\u914d\u65b9\u5976\u7c89\u7f51\u7edc\u8d44\u6e90<\/strong> \u4ee5\u53ca\u65b0 <strong>\u5df2\u516c\u5e03\u7684\u5e02\u573a\u6e05\u5355<\/strong> \u786e\u4fdd\u5185\u90e8\u8bb0\u5f55\u4e0e\u9762\u5411\u516c\u4f17\u7684\u4ea7\u54c1\u4fe1\u606f\u4fdd\u6301\u4e00\u81f4\u3002.<\/p>\n<p>\u76d1\u7ba1\u3001\u8d28\u91cf\u548c\u5546\u4e1a\u56e2\u961f\u5e94\u6838\u5b9e\uff1a <strong>\u4ea7\u54c1\u5217\u8868\u548c\u516c\u53f8\u4fe1\u606f\u5747\u51c6\u786e\u65e0\u8bef\u3002<\/strong> \u5728\u516c\u5171\u6570\u636e\u5e93\u4e2d\u3002\u5404\u7ec4\u7ec7\u8fd8\u53ef\u4ee5\u8003\u8651\u76d1\u6d4b\u672a\u6765\u7684\u900f\u660e\u5ea6\u4e3e\u63aa\u3002 <strong>\u9e73\u9e1f\u884c\u52a8\u901f\u5ea6<\/strong> \u968f\u65f6\u4e86\u89e3\u6f5c\u5728\u7684\u653f\u7b56\u53d1\u5c55\u6216\u76d1\u7ba1\u63aa\u65bd\u3002.<\/p>\n<p>\u968f\u7740\u76d1\u7ba1\u900f\u660e\u5ea6\u4e3e\u63aa\u7684\u4e0d\u65ad\u53d1\u5c55\uff0c\u4fdd\u6301\u5bf9\u5168\u7403\u76d1\u7ba1\u52a8\u6001\u7684\u4e86\u89e3\u53d8\u5f97\u8d8a\u6765\u8d8a\u91cd\u8981\u3002. <a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u5e2e\u52a9\u7ec4\u7ec7\u76d1\u63a7\u76d1\u7ba1\u52a8\u6001\u5e76\u7ba1\u7406\u8de8\u591a\u4e2a\u53f8\u6cd5\u7ba1\u8f96\u533a\u7684\u5de5\u4f5c\u6d41\u7a0b\u5408\u89c4\u6027\u3002.<\/p>\n<p><a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u662f\u4e00\u4e2a\u9886\u5148\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u76d1\u7ba1\u60c5\u62a5\u548c\u5de5\u4f5c\u6d41\u7a0b\u7f16\u6392\u5e73\u53f0\uff0c\u5b83\u8d4b\u80fd\u5168\u7403\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u7ec4\u7ec7\uff08\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\uff09\uff0c\u4f7f\u5176\u80fd\u591f\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002. <strong>\u901a\u8fc7\u5c06\u5148\u8fdb\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4e0e\u4e13\u5bb6\u56e2\u961f\u76f8\u7ed3\u5408\uff0c, <a href=\"http:\/\/regask.com\/zh\/\">RegASK<\/a><\/strong> \u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u3001\u53ef\u64cd\u4f5c\u7684\u6d1e\u5bdf\u548c\u7aef\u5230\u7aef\u7684\u81ea\u52a8\u5316\uff0c\u7b80\u5316\u5408\u89c4\u6d41\u7a0b\uff0c\u964d\u4f4e\u98ce\u9669\uff0c\u5e76\u52a0\u901f\u8fdb\u5165 160 \u591a\u4e2a\u56fd\u5bb6\u7684\u5e02\u573a\u3002. <a href=\"http:\/\/regask.com\/zh\/\"><strong>\u4e86\u89e3\u66f4\u591a <\/strong><\/a>\u6216\u8005<strong><a href=\"https:\/\/regask.com\/zh\/%e9%a2%84%e8%ae%a2%e6%bc%94%e7%a4%ba\/\"> \u7acb\u5373\u9884\u8ba2\u6f14\u793a\u3002<\/a>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1433083344 > .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-1415151851\">\n\n\t<div id=\"col-916524592\" 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>\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/h3>\n\t<div id=\"gap-1223132954\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1223132954 {\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\">FDA\u5173\u4e8e\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\u6743\u7684\u6307\u5bfc\u610f\u89c1\u8349\u6848\u662f\u4ec0\u4e48\uff1f<\/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-1877511125\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1877511125 {\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\">\u8fd9\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\u4e8e3\u67084\u65e5\u53d1\u5e03\u4e86\u6307\u5bfc\u8349\u6848\uff0c,\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>\u4e3a\u5bfb\u6c42\u5e2e\u52a9\u7684\u7533\u8bf7\u4eba\u63d0\u4f9b\u5efa\u8bae<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\">\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\u6743<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0\u4e3a\u4e86\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\u836f\u7533\u8bf7\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\">\u6216\u8005<\/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\u8865\u5145\u5242<\/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\">\u5b83\u89e3\u91ca\u4e86\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\">\u8d44\u683c\u6807\u51c6<\/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>\u5e76\u6982\u8ff0\u4e86\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\u548c\u683c\u5f0f<\/span><\/span><span class=\"TextRun SCXW263241192 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW263241192 BCX0\">\u00a0\u9884\u8ba1\u4f1a\u6536\u5230\u72ec\u5bb6\u4ee3\u7406\u8bf7\u6c42\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-916524592 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1644833658\" 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\">\u54ea\u4e9b\u4eba\u53ef\u4ee5\u7533\u8bf7\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\u6743\uff1f<\/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-1081909426\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1081909426 {\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\">\u7533\u8bf7\u4eba\u00a0<\/span><span class=\"NormalTextRun SCXW124616724 BCX0\">\u63d0\u4ea4<\/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\">\u7531\u65b0\u7684\u4e34\u5e8a\u7814\u7a76\u652f\u6301\u7684\u539f\u59cb\u65b0\u836f\u7533\u8bf7\u6216\u65b0\u836f\u7533\u8bf7\u8865\u5145\u7533\u8bf7<\/span><\/span><\/strong><span class=\"TextRun SCXW124616724 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW124616724 BCX0\">\u00a0\u53ef\u4ee5\u8bf7\u6c42\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\">\u4e09\u5e74\u72ec\u5bb6\u4ee3\u7406\u6743<\/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> \u524d\u63d0\u662f\u5b83\u4eec\u7b26\u5408\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u89c4\u5b9a\u7684\u6cd5\u5b9a\u548c\u76d1\u7ba1\u8d44\u683c\u8981\u6c42\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-1644833658 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-43787854\" 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\">\u622a\u6b62\u65e5\u671f\u662f\u4ec0\u4e48\u65f6\u5019\uff1f\u00a0<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">\u63d0\u4ea4<\/span><span class=\"NormalTextRun SCXW110399116 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0\u5bf9FDA\u6307\u5357\u8349\u6848\u6709\u4f55\u8bc4\u8bba\uff1f<\/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-845434899\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-845434899 {\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\u76ca\u76f8\u5173\u8005\u53ef\u80fd\u00a0<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">\u63d0\u4ea4<\/span><span class=\"NormalTextRun SCXW109329519 BCX0\">\u00a0\u5173\u4e8e\u53cd\u9988\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\">\u6307\u5bfc\u8349\u6848<\/span><\/span><\/strong><span class=\"TextRun SCXW109329519 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW109329519 BCX0\">\u76f4\u5230<\/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> \u5229\u7528FDA\u7684\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\">\u5728\u7ebf\u6216\u4e66\u9762\u63d0\u4ea4\u6e20\u9053<\/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-43787854 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1589788906\" 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 \u5982\u4f55\u4e3a\u7ba1\u7406\u8f6c\u57fa\u56e0\u751f\u7269\u6807\u7b7e\u8981\u6c42\u7684\u516c\u53f8\u63d0\u4f9b\u652f\u6301\uff1f<\/h4>\n\t<div id=\"gap-1550033551\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1550033551 {\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\/zh\/\"><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW19024172 BCX0\">RegASK<\/span><\/strong><\/a><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0\u63d0\u4f9b\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\">\u4eba\u5de5\u667a\u80fd\u9a71\u52a8\u7684\u76d1\u7ba1\u667a\u80fd\u548c\u5de5\u4f5c\u6d41\u7a0b\u81ea\u52a8\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\u8fd9\u4f7f\u5f97\u7ec4\u7ec7\u80fd\u591f\u00a0<\/span><span class=\"NormalTextRun SCXW19024172 BCX0\">\u76d1\u89c6\u5668<\/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 BCX0\">FDA\u6307\u5357\u66f4\u65b0\u3001\u6cd5\u89c4\u53d8\u66f4\u548c\u63d0\u4ea4\u8981\u6c42<\/span><\/span><\/strong><span class=\"TextRun SCXW19024172 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW19024172 BCX0\">\u00a0\u5728\u5168\u7403\u5e02\u573a\u8303\u56f4\u5185\u3002\u8fd9\u6709\u52a9\u4e8e\u76d1\u7ba1\u548c\u5408\u89c4\u56e2\u961f\u53ca\u65f6\u4e86\u89e3\u6700\u65b0\u4fe1\u606f\u3001\u8bc4\u4f30\u76d1\u7ba1\u5f71\u54cd\u5e76\u7b80\u5316\u7533\u62a5\u51c6\u5907\u5de5\u4f5c\u3002.<\/span><\/span><span class=\"EOP SCXW19024172 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-1589788906 > .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\u00a0March 4, 2026, the\u00a0U.S. Food and Drug Administration (FDA)\u00a0published a\u00a0draft guidance document\u00a0addressing\u00a0three-year clinical investigation exclusivity\u00a0for drug products. The guidance clarifies regulatory expectations for applicants seeking exclusivity for\u00a0new drug applications (NDAs)\u00a0and\u00a0NDA supplements, particularly when new clinical investigations support these submissions.\u00a0 The draft guidance is intended to help applicants understand the\u00a0statutory and regulatory eligibility criteria\u00a0required\u00a0to obtain\u00a03-year exclusivity&#8230;.<\/p>","protected":false},"author":41,"featured_media":9621,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,33,39],"tags":[],"class_list":["post-9620","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-news","category-medical-devices-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Issues Draft Guidance on Three-Year Exclusivity<\/title>\n<meta name=\"description\" content=\"Explore the FDA&#039;s draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. Learn more today.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/zh\/fda\u53d1\u5e03\u5173\u4e8e\u65b0\u836f\u7533\u8bf7\u548c\u8865\u5145\u7533\u8bf7\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Draft Guidance on Three-Year Clinical Investigation Exclusivity for NDAs and Supplements\" \/>\n<meta property=\"og:description\" content=\"Explore the FDA&#039;s draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. Learn more today.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/fda\u53d1\u5e03\u5173\u4e8e\u65b0\u836f\u7533\u8bf7\u548c\u8865\u5145\u7533\u8bf7\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-11T06:41:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-11T07:50:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Shaffa Renaningtyas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Shaffa Renaningtyas\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/\"},\"author\":{\"name\":\"Shaffa Renaningtyas\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\"},\"headline\":\"FDA Issues Draft Guidance on Three-Year Clinical Invest&hellip;\",\"datePublished\":\"2026-03-11T06:41:45+00:00\",\"dateModified\":\"2026-03-11T07:50:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/\"},\"wordCount\":1037,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png\",\"articleSection\":[\"United States\",\"Regulatory News\",\"Medical Devices\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/\",\"name\":\"FDA Issues Draft Guidance on Three-Year Exclusivity\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png\",\"datePublished\":\"2026-03-11T06:41:45+00:00\",\"dateModified\":\"2026-03-11T07:50:07+00:00\",\"description\":\"Explore the FDA's draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. Learn more today.\",\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png\",\"width\":800,\"height\":600,\"caption\":\"Fda Issues Draft Guidance Three Year Clinical Investigation Exclusivity Ndas Supplements\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\",\"name\":\"Shaffa Renaningtyas\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA\u53d1\u5e03\u4e09\u5e74\u72ec\u5360\u671f\u6307\u5bfc\u8349\u6848","description":"\u4e86\u89e3FDA\u5173\u4e8e\u65b0\u836f\u7533\u8bf7\u548c\u8865\u5145\u7533\u8bf7\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\u6743\u7684\u6307\u5bfc\u8349\u6848\u3002\u7acb\u5373\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\u3002.","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:\/\/regask.com\/zh\/fda\u53d1\u5e03\u5173\u4e8e\u65b0\u836f\u7533\u8bf7\u548c\u8865\u5145\u7533\u8bf7\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\/","og_locale":"zh_CN","og_type":"article","og_title":"FDA Issues Draft Guidance on Three-Year Clinical Investigation Exclusivity for NDAs and Supplements","og_description":"Explore the FDA's draft guidance on three-year clinical investigation exclusivity for NDAs and supplements. Learn more today.","og_url":"https:\/\/regask.com\/zh\/fda\u53d1\u5e03\u5173\u4e8e\u65b0\u836f\u7533\u8bf7\u548c\u8865\u5145\u7533\u8bf7\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-03-11T06:41:45+00:00","article_modified_time":"2026-03-11T07:50:07+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png","type":"image\/png"}],"author":"Shaffa Renaningtyas","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"\u4f5c\u8005":"Shaffa Renaningtyas","\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4":"5 \u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/#article","isPartOf":{"@id":"https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/"},"author":{"name":"Shaffa Renaningtyas","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6"},"headline":"FDA Issues Draft Guidance on Three-Year Clinical Invest&hellip;","datePublished":"2026-03-11T06:41:45+00:00","dateModified":"2026-03-11T07:50:07+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/"},"wordCount":1037,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png","articleSection":["United States","Regulatory News","Medical Devices"],"inLanguage":"zh-Hans"},{"@type":"WebPage","@id":"https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/","url":"https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/","name":"FDA\u53d1\u5e03\u4e09\u5e74\u72ec\u5360\u671f\u6307\u5bfc\u8349\u6848","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png","datePublished":"2026-03-11T06:41:45+00:00","dateModified":"2026-03-11T07:50:07+00:00","description":"\u4e86\u89e3FDA\u5173\u4e8e\u65b0\u836f\u7533\u8bf7\u548c\u8865\u5145\u7533\u8bf7\u4e09\u5e74\u4e34\u5e8a\u7814\u7a76\u72ec\u5360\u6743\u7684\u6307\u5bfc\u8349\u6848\u3002\u7acb\u5373\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\u3002.","inLanguage":"zh-Hans","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/"]}]},{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/fda-issues-draft-guidance-on-three-year-clinical-investigation-exclusivity-for-ndas-and-supplements\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/fda-issues-draft-guidance-three-year-clinical-investigation-exclusivity-ndas-supplements.png","width":800,"height":600,"caption":"Fda Issues Draft Guidance Three Year Clinical Investigation Exclusivity Ndas Supplements"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"\u52a9\u529b\u66f4\u660e\u667a\u7684\u76d1\u7ba1\u51b3\u7b56","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-Hans"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6","name":"\u6c99\u6cd5\u00b7\u96f7\u7eb3\u5b81\u8482\u4e9a\u65af"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/9620","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/users\/41"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/comments?post=9620"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/9620\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media\/9621"}],"wp:attachment":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media?parent=9620"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/categories?post=9620"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/tags?post=9620"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}