{"id":8128,"date":"2024-05-29T11:43:09","date_gmt":"2024-05-29T03:43:09","guid":{"rendered":"https:\/\/greenoo.tw\/?p=8128"},"modified":"2026-01-27T10:11:04","modified_gmt":"2026-01-27T02:11:04","slug":"fda-fast-track-designation-timeline-explained-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/fda-fast-track-designation-timeline-explained-2026\/","title":{"rendered":"\u7f8e\u570b FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u5230\u5e95\u6709\u591a\u5feb?\u5f9e\u7533\u8acb\u5230\u6838\u51c6\u7684\u5b8c\u6574\u6642\u7a0b\u89e3\u6790(2026 \u6700\u65b0)"},"content":{"rendered":"<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-20040\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-feature-2026.png\" alt=\"FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u6642\u7a0b\u89e3\u6790\u5c01\u9762,\u986f\u793a\u6642\u9418\u8207\u5be9\u67e5\u6587\u4ef6\u5716\u793a,\u8aaa\u660e 2026 \u6700\u65b0\u7533\u8acb\u5230\u6838\u51c6\u6642\u7a0b\" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h2>\n<h2>FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u7684\u300c\u5feb\u300d,\u6307\u7684\u4e0d\u662f\u6838\u51c6\u901f\u5ea6<\/h2>\n<p>\u6839\u64da <a href=\"https:\/\/www.fda.gov\/patients\/fast-track-breakthrough-therapy-accelerated-approval-priority-review\/fast-track\" target=\"_blank\" rel=\"noopener\">FDA \u5feb\u901f\u901a\u9053\u8a08\u756b\u5b98\u65b9\u8aaa\u660e<\/a>{:target=&#8221;_blank&#8221;},\u5feb\u901f\u901a\u9053\u8a8d\u5b9a(Fast Track Designation)\u7684\u6838\u5fc3\u76ee\u7684\u662f<strong>\u52a0\u901f\u958b\u767c\u8207\u5be9\u67e5\u6d41\u7a0b<\/strong>,\u800c\u975e\u7e2e\u77ed\u6700\u7d42\u6838\u51c6\u6642\u9593\u3002\u5be6\u969b\u4e0a,\u5f9e\u63d0\u4ea4\u5feb\u901f\u901a\u9053\u7533\u8acb\u5230\u53d6\u5f97\u8a8d\u5b9a,\u901a\u5e38\u9700\u8981 <strong>60 \u5929<\/strong>;\u800c\u5f9e\u8a8d\u5b9a\u5230\u6700\u7d42\u7522\u54c1\u6838\u51c6,\u5247\u53ef\u80fd\u9700\u8981 <strong>\u6578\u500b\u6708\u81f3\u6578\u5e74<\/strong>,\u53d6\u6c7a\u65bc\u81e8\u5e8a\u8a66\u9a57\u9032\u5ea6\u3001\u8cc7\u6599\u5b8c\u6574\u6027\u8207\u75be\u75c5\u985e\u5225\u3002<\/p>\n<p>\u53f0\u7063\u91ab\u85e5\u696d\u8005\u5e38\u898b\u7684\u4e09\u5927\u8aa4\u89e3\u5305\u62ec:<\/p>\n<ul>\n<li><strong>\u8aa4\u89e3\u4e00<\/strong>: \u5feb\u901f\u901a\u9053 = \u5feb\u901f\u6838\u51c6(\u5be6\u969b\u4e0a\u662f\u52a0\u901f\u5be9\u67e5,\u975e\u4fdd\u8b49\u6838\u51c6)<\/li>\n<li><strong>\u8aa4\u89e3\u4e8c<\/strong>: \u7533\u8acb\u5f8c\u7acb\u5373\u751f\u6548(\u5be6\u969b\u9700 60 \u5929\u5be9\u67e5\u671f)<\/li>\n<li><strong>\u8aa4\u89e3\u4e09<\/strong>: \u9069\u7528\u6240\u6709\u85e5\u54c1(\u50c5\u9650\u56b4\u91cd\u75be\u75c5\u4e14\u6709\u672a\u6eff\u8db3\u91ab\u7642\u9700\u6c42)<\/li>\n<\/ul>\n<p>\u82e5\u5c0d FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u7684\u6574\u9ad4\u5236\u5ea6\u8207\u7533\u8acb\u8cc7\u683c\u4ecd\u4e0d\u6e05\u695a,\u5efa\u8b70\u5148\u5f9e\u5b8c\u6574\u7684 FDA \u85e5\u54c1\u5be9\u67e5\u5236\u5ea6\u7406\u89e3\u8d77,\u6709\u52a9\u65bc\u5f8c\u7e8c\u5224\u65b7\u4e0d\u540c\u52a0\u901f\u8def\u5f91\u7684\u9069\u7528\u6027\u8207\u6642\u7a0b\u898f\u5283\u3002<\/p>\n<hr \/>\n<h2>\u70ba\u4f55\u53f0\u7063\u91ab\u85e5\u696d\u8005\u9700\u8981\u4e86\u89e3\u5feb\u901f\u901a\u9053\u6642\u7a0b?<\/h2>\n<p>FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u662f\u7f8e\u570b\u70ba\u52a0\u901f\u6cbb\u7642\u56b4\u91cd\u75be\u75c5\u85e5\u54c1\u4e0a\u5e02\u800c\u8a2d\u7acb\u7684\u5236\u5ea6,\u4f46\u300c\u52a0\u901f\u300d\u7684\u7bc4\u570d\u8207\u5be6\u969b\u6642\u7a0b\u5e38\u88ab\u8aa4\u89e3\u3002\u53f0\u7063\u91ab\u85e5\u696d\u8005\u82e5\u8a08\u5283\u900f\u904e\u5feb\u901f\u901a\u9053\u9032\u5165\u7f8e\u570b\u5e02\u5834,\u5fc5\u9808\u7406\u89e3:<\/p>\n<ol>\n<li><strong>\u6642\u7a0b\u898f\u5283<\/strong>: \u5feb\u901f\u901a\u9053\u4e26\u975e\u300c\u7533\u8acb\u5f8c\u7acb\u5373\u52a0\u901f\u300d,\u800c\u662f\u9700\u7d93\u904e\u6b63\u5f0f\u5be9\u67e5\u8207\u8a8d\u5b9a\u7a0b\u5e8f<\/li>\n<li><strong>\u8cc7\u6e90\u914d\u7f6e<\/strong>: \u8a8d\u5b9a\u5f8c\u53ef\u4eab\u6709\u7684\u5be9\u67e5\u512a\u52e2(\u5982\u6efe\u52d5\u5be9\u67e5\u3001\u512a\u5148\u5be9\u67e5),\u9700\u63d0\u524d\u6e96\u5099\u76f8\u61c9\u8cc7\u6599<\/li>\n<li><strong>\u6295\u8cc7\u6c7a\u7b56<\/strong>: \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u4e0d\u4fdd\u8b49\u6700\u7d42\u6838\u51c6,\u6642\u7a0b\u9810\u4f30\u5f71\u97ff\u81e8\u5e8a\u8a66\u9a57\u8207\u5546\u696d\u5316\u898f\u5283<\/li>\n<\/ol>\n<p>\u6839\u64da <a href=\"https:\/\/www.fda.gov\/regulatory-information\/selected-amendments-fdc-act\/food-and-drug-administration-safety-and-innovation-act-fdasia\" target=\"_blank\" rel=\"noopener\">FDASIA(FDA \u5b89\u5168\u8207\u5275\u65b0\u6cd5\u6848)<\/a>{:target=&#8221;_blank&#8221;},\u5feb\u901f\u901a\u9053\u8a08\u756b\u65bc 2012 \u5e74\u6b63\u5f0f\u6cd5\u5236\u5316,\u65e8\u5728\u7e2e\u77ed\u56b4\u91cd\u75be\u75c5\u6cbb\u7642\u85e5\u54c1\u7684\u958b\u767c\u6642\u7a0b,\u4f46\u5be6\u969b\u57f7\u884c\u6642\u7a0b\u4ecd\u53d7\u591a\u91cd\u56e0\u7d20\u5f71\u97ff\u3002<\/p>\n<p>\u82e5\u5c1a\u672a\u5efa\u7acb\u5c0d FDA \u98df\u54c1\u8a3b\u518a\u5236\u5ea6\u7684\u6574\u9ad4\u7406\u89e3,\u5efa\u8b70\u5148\u5f9e\u5b8c\u6574\u7e3d\u89bd\u5165\u624b,\u6709\u52a9\u65bc\u5f8c\u7e8c\u5224\u65b7\u4e0d\u540c\u60c5\u5883\u8207\u57f7\u884c\u5dee\u7570\u3002<\/p>\n<p>\ud83d\udc49 <strong>FDA \u98df\u54c1\u8a3b\u518a\u5b8c\u6574\u6307\u5357|\u53f0\u7063\u98df\u54c1\u51fa\u53e3\u7f8e\u570b\u5fc5\u8b80(2026 \u6700\u65b0)<\/strong><br \/>\n<a href=\"https:\/\/greenoo.tw\/zh\/fda-food-registration\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration\/<\/a><\/p>\n<hr \/>\n<h2>FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u7684\u5b8c\u6574\u6642\u7a0b\u62c6\u89e3<\/h2>\n<h3>\u968e\u6bb5\u4e00:\u7533\u8acb\u524d\u6e96\u5099(3-6 \u500b\u6708)<\/h3>\n<p>\u5728\u6b63\u5f0f\u63d0\u4ea4\u5feb\u901f\u901a\u9053\u7533\u8acb\u524d,\u696d\u8005\u9700\u5b8c\u6210\u4ee5\u4e0b\u6e96\u5099:<\/p>\n<ul>\n<li><strong>\u75be\u75c5\u56b4\u91cd\u6027\u8a55\u4f30<\/strong>: \u78ba\u8a8d\u76ee\u6a19\u75be\u75c5\u7b26\u5408 FDA \u5b9a\u7fa9\u7684\u300c\u56b4\u91cd\u75be\u75c5\u300d(\u5982\u764c\u75c7\u3001\u7f55\u898b\u75be\u75c5\u3001\u5371\u53ca\u751f\u547d\u7684\u611f\u67d3\u75c7)<\/li>\n<li><strong>\u672a\u6eff\u8db3\u91ab\u7642\u9700\u6c42\u8b49\u660e<\/strong>: \u6e96\u5099\u73fe\u6709\u6cbb\u7642\u9078\u9805\u4e0d\u8db3\u7684\u79d1\u5b78\u8b49\u64da<\/li>\n<li><strong>\u521d\u6b65\u81e8\u5e8a\u6578\u64da<\/strong>: \u81f3\u5c11\u9700\u6709\u7b2c\u4e00\u671f\u81e8\u5e8a\u8a66\u9a57\u6578\u64da,\u986f\u793a\u6f5b\u5728\u7642\u6548<\/li>\n<li><strong>\u958b\u767c\u8a08\u756b\u66f8<\/strong>: \u8a73\u7d30\u8aaa\u660e\u5f8c\u7e8c\u81e8\u5e8a\u8a66\u9a57\u8a2d\u8a08\u8207\u6642\u7a0b<\/li>\n<\/ul>\n<p>\u4f9d\u64da <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-312.81\" target=\"_blank\" rel=\"noopener\">CFR Title 21 \u00a7 312.81<\/a>{:target=&#8221;_blank&#8221;},\u5feb\u901f\u901a\u9053\u7533\u8acb\u5fc5\u9808\u5305\u542b\u300c\u85e5\u54c1\u7528\u65bc\u6cbb\u7642\u56b4\u91cd\u75be\u75c5\u4e14\u6709\u6f5b\u529b\u6eff\u8db3\u672a\u6eff\u8db3\u91ab\u7642\u9700\u6c42\u300d\u7684\u5145\u5206\u8b49\u64da\u3002<\/p>\n<h3>\u968e\u6bb5\u4e8c:\u5feb\u901f\u901a\u9053\u7533\u8acb\u63d0\u4ea4\u8207\u5be9\u67e5(60 \u5929)<\/h3>\n<p>\u6b63\u5f0f\u63d0\u4ea4\u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u7533\u8acb\u5f8c,FDA \u7684\u6a19\u6e96\u5be9\u67e5\u6642\u7a0b\u70ba <strong>60 \u5929<\/strong>:<\/p>\n<ul>\n<li><strong>\u63d0\u4ea4\u65b9\u5f0f<\/strong>: \u900f\u904e IND(Investigational New Drug Application)\u6216 NDA(New Drug Application)\u7a0b\u5e8f\u63d0\u4ea4<\/li>\n<li><strong>\u5be9\u67e5\u91cd\u9ede<\/strong>: FDA \u8a55\u4f30\u75be\u75c5\u56b4\u91cd\u6027\u3001\u672a\u6eff\u8db3\u91ab\u7642\u9700\u6c42\u3001\u521d\u6b65\u81e8\u5e8a\u6578\u64da<\/li>\n<li><strong>\u6e9d\u901a\u6a5f\u5236<\/strong>: \u5be9\u67e5\u671f\u9593 FDA \u53ef\u80fd\u8981\u6c42\u88dc\u5145\u8cc7\u6599\u6216\u53ec\u958b\u6703\u8b70\u6f84\u6e05\u7591\u554f<\/li>\n<\/ul>\n<p><strong>\u5be6\u52d9\u6ce8\u610f<\/strong>: 60 \u5929\u70ba\u300c\u6a19\u6e96\u6642\u7a0b\u300d,\u82e5\u8cc7\u6599\u4e0d\u5b8c\u6574\u6216\u9700\u88dc\u4ef6,\u5be9\u67e5\u6642\u9593\u53ef\u80fd\u5ef6\u9577\u81f3 90-120 \u5929\u3002<\/p>\n<hr \/>\n<h3>\u5716 2: FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u6642\u7a0b\u6d41\u7a0b\u5716<\/h3>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20041\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-flowchart-2026.png\" alt=\"FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u6642\u7a0b\u6d41\u7a0b\u5716,\u986f\u793a\u5f9e\u7533\u8acb\u524d\u6e96\u5099\u5230\u6700\u7d42\u6838\u51c6\u7684 4 \u500b\u968e\u6bb5,\u5305\u542b\u5404\u968e\u6bb5\u6642\u7a0b\u8207\u91cd\u9ede\u8aaa\u660e\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-flowchart-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-flowchart-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-flowchart-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-flowchart-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-flowchart-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<hr \/>\n<h3>\u968e\u6bb5\u4e09:\u8a8d\u5b9a\u5f8c\u7684\u52a0\u901f\u958b\u767c(1-3 \u5e74)<\/h3>\n<p>\u53d6\u5f97\u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u5f8c,\u696d\u8005\u53ef\u4eab\u6709\u4ee5\u4e0b\u5be9\u67e5\u512a\u52e2,\u4f46\u958b\u767c\u6642\u7a0b\u4ecd\u53d6\u6c7a\u65bc\u81e8\u5e8a\u8a66\u9a57\u9032\u5ea6:<\/p>\n<p><strong>\u6efe\u52d5\u5be9\u67e5(Rolling Review)<\/strong>:<\/p>\n<ul>\n<li>\u5141\u8a31\u5206\u6279\u63d0\u4ea4 NDA\/BLA \u8cc7\u6599,\u7121\u9700\u7b49\u5f85\u6240\u6709\u6578\u64da\u5b8c\u6210<\/li>\n<li>\u53ef\u7e2e\u77ed\u6700\u7d42\u5be9\u67e5\u6642\u7a0b\u7d04 2-4 \u500b\u6708<\/li>\n<\/ul>\n<p><strong>\u512a\u5148\u5be9\u67e5\u8cc7\u683c<\/strong>:<\/p>\n<ul>\n<li>\u82e5\u7b26\u5408\u689d\u4ef6,\u53ef\u7533\u8acb\u512a\u5148\u5be9\u67e5(Priority Review),\u5be9\u67e5\u6642\u7a0b\u5f9e\u6a19\u6e96 10 \u500b\u6708\u7e2e\u77ed\u81f3 6 \u500b\u6708<\/li>\n<\/ul>\n<p><strong>\u983b\u7e41\u6e9d\u901a<\/strong>:<\/p>\n<ul>\n<li>FDA \u63d0\u4f9b\u66f4\u5bc6\u96c6\u7684\u6703\u8b70\u8207\u6307\u5c0e,\u5354\u52a9\u89e3\u6c7a\u958b\u767c\u904e\u7a0b\u4e2d\u7684\u6280\u8853\u554f\u984c<\/li>\n<\/ul>\n<p><strong>\u5be6\u52d9\u6848\u4f8b<\/strong>: \u67d0\u7f55\u898b\u764c\u75c7\u85e5\u54c1\u53d6\u5f97\u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u5f8c,\u900f\u904e\u6efe\u52d5\u5be9\u67e5\u63d0\u4ea4\u7b2c\u4e09\u671f\u81e8\u5e8a\u6578\u64da,\u6700\u7d42\u5f9e\u8a8d\u5b9a\u5230\u6838\u51c6\u6b77\u6642 18 \u500b\u6708,\u8f03\u50b3\u7d71\u8def\u5f91\u7e2e\u77ed\u7d04 12 \u500b\u6708\u3002<\/p>\n<h3>\u968e\u6bb5\u56db:\u6700\u7d42\u6838\u51c6(6-10 \u500b\u6708)<\/h3>\n<p>\u5b8c\u6210\u6240\u6709\u81e8\u5e8a\u8a66\u9a57\u4e26\u63d0\u4ea4\u5b8c\u6574 NDA\/BLA \u5f8c,FDA \u7684\u5be9\u67e5\u6642\u7a0b\u70ba:<\/p>\n<ul>\n<li><strong>\u512a\u5148\u5be9\u67e5<\/strong>: 6 \u500b\u6708(\u9069\u7528\u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u85e5\u54c1)<\/li>\n<li><strong>\u6a19\u6e96\u5be9\u67e5<\/strong>: 10 \u500b\u6708(\u82e5\u672a\u53d6\u5f97\u512a\u5148\u5be9\u67e5\u8cc7\u683c)<\/li>\n<\/ul>\n<p><strong>\u91cd\u8981\u63d0\u9192<\/strong>: \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u4e0d\u4fdd\u8b49\u6700\u7d42\u6838\u51c6,FDA \u4ecd\u6703\u56b4\u683c\u5be9\u67e5\u5b89\u5168\u6027\u8207\u7642\u6548\u6578\u64da\u3002<\/p>\n<hr \/>\n<h2>\u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u7684\u5be6\u969b\u6642\u7a0b\u5f71\u97ff\u56e0\u7d20<\/h2>\n<p>\u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u7684\u300c\u5feb\u300d\u53d7\u4ee5\u4e0b\u56e0\u7d20\u5f71\u97ff:<\/p>\n<div class=\"MarkdownTable_tableContainer__2k5Kh\" tabindex=\"0\" role=\"region\">\n<table>\n<thead>\n<tr>\n<th>\u5f71\u97ff\u56e0\u7d20<\/th>\n<th>\u8aaa\u660e<\/th>\n<th>\u6642\u7a0b\u5f71\u97ff<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u75be\u75c5\u985e\u5225<\/strong><\/td>\n<td>\u7f55\u898b\u75be\u75c5\u3001\u764c\u75c7\u512a\u5148\u7a0b\u5ea6\u8f03\u9ad8<\/td>\n<td>\u53ef\u7e2e\u77ed 3-6 \u500b\u6708<\/td>\n<\/tr>\n<tr>\n<td><strong>\u81e8\u5e8a\u6578\u64da\u5b8c\u6574\u6027<\/strong><\/td>\n<td>\u7b2c\u4e09\u671f\u81e8\u5e8a\u8a66\u9a57\u6578\u64da\u662f\u5426\u5145\u5206<\/td>\n<td>\u4e0d\u5b8c\u6574\u53ef\u80fd\u5ef6\u9577 6-12 \u500b\u6708<\/td>\n<\/tr>\n<tr>\n<td><strong>FDA \u6e9d\u901a\u983b\u7387<\/strong><\/td>\n<td>\u4e3b\u52d5\u8207 FDA \u6e9d\u901a\u53ef\u6e1b\u5c11\u88dc\u4ef6\u6b21\u6578<\/td>\n<td>\u53ef\u907f\u514d 2-4 \u500b\u6708\u5ef6\u8aa4<\/td>\n<\/tr>\n<tr>\n<td><strong>\u6efe\u52d5\u5be9\u67e5\u57f7\u884c<\/strong><\/td>\n<td>\u662f\u5426\u5584\u7528\u6efe\u52d5\u5be9\u67e5\u5206\u6279\u63d0\u4ea4<\/td>\n<td>\u53ef\u7e2e\u77ed 2-4 \u500b\u6708<\/td>\n<\/tr>\n<tr>\n<td><strong>\u512a\u5148\u5be9\u67e5\u8cc7\u683c<\/strong><\/td>\n<td>\u662f\u5426\u540c\u6642\u53d6\u5f97\u512a\u5148\u5be9\u67e5<\/td>\n<td>\u53ef\u7e2e\u77ed 4 \u500b\u6708<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<hr \/>\n<h3>\u5716 3: FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u6642\u7a0b\u5f71\u97ff\u56e0\u7d20\u6aa2\u6838\u8868<\/h3>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20042\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-factors-checklist-2026.png\" alt=\"FDA \u5feb\u901f\u901a\u9053\u6642\u7a0b\u5f71\u97ff\u56e0\u7d20\u6aa2\u6838\u8868,\u5217\u51fa 8 \u9805\u8a55\u4f30\u85e5\u54c1\u958b\u767c\u6642\u7a0b\u7684\u95dc\u9375\u56e0\u7d20,\u5305\u542b\u75be\u75c5\u985e\u5225\u3001\u81e8\u5e8a\u9032\u5ea6\u7b49\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-factors-checklist-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-factors-checklist-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-factors-checklist-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-factors-checklist-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-fast-track-designation-timeline-factors-checklist-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<p>&nbsp;<\/p>\n<hr \/>\n<h2>\u9700\u8981\u7279\u5225\u6ce8\u610f\u7684 3 \u500b\u6642\u7a0b\u8aa4\u5340<\/h2>\n<h3>\u8aa4\u5340\u4e00:\u5feb\u901f\u901a\u9053 = \u5feb\u901f\u6838\u51c6<\/h3>\n<p>\u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u50c5\u662f\u300c\u52a0\u901f\u5be9\u67e5\u6d41\u7a0b\u300d,\u4e26\u975e\u300c\u4fdd\u8b49\u5feb\u901f\u6838\u51c6\u300d\u3002FDA \u4ecd\u6703\u56b4\u683c\u5be9\u67e5\u5b89\u5168\u6027\u8207\u7642\u6548,\u82e5\u6578\u64da\u4e0d\u8db3,\u6838\u51c6\u6642\u7a0b\u4e0d\u6703\u7e2e\u77ed\u3002<\/p>\n<h3>\u8aa4\u5340\u4e8c:\u7533\u8acb\u5f8c\u7acb\u5373\u4eab\u6709\u512a\u52e2<\/h3>\n<p>\u5feb\u901f\u901a\u9053\u7533\u8acb\u9700\u7d93 60 \u5929\u5be9\u67e5\u671f,\u4e14\u8a8d\u5b9a\u5f8c\u7684\u6efe\u52d5\u5be9\u67e5\u3001\u512a\u5148\u5be9\u67e5\u4ecd\u9700\u7b26\u5408\u984d\u5916\u689d\u4ef6,\u4e26\u975e\u81ea\u52d5\u4eab\u6709\u3002<\/p>\n<h3>\u8aa4\u5340\u4e09:\u6240\u6709\u85e5\u54c1\u90fd\u80fd\u7533\u8acb<\/h3>\n<p>\u5feb\u901f\u901a\u9053\u50c5\u9069\u7528\u65bc\u300c\u6cbb\u7642\u56b4\u91cd\u75be\u75c5\u4e14\u6709\u672a\u6eff\u8db3\u91ab\u7642\u9700\u6c42\u300d\u7684\u85e5\u54c1,\u4e00\u822c\u6162\u6027\u75c5\u6216\u751f\u6d3b\u54c1\u8cea\u6539\u5584\u85e5\u54c1\u4e0d\u7b26\u5408\u8cc7\u683c\u3002<\/p>\n<hr \/>\n<h2>\u7e3d\u7d50<\/h2>\n<ul>\n<li>FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u7684\u300c\u5feb\u300d\u6307\u52a0\u901f\u5be9\u67e5\u6d41\u7a0b,\u975e\u4fdd\u8b49\u5feb\u901f\u6838\u51c6<\/li>\n<li>\u5f9e\u7533\u8acb\u5230\u8a8d\u5b9a\u9700 <strong>60 \u5929<\/strong>,\u5f9e\u8a8d\u5b9a\u5230\u6838\u51c6\u9700 <strong>1-3 \u5e74<\/strong>(\u4f9d\u81e8\u5e8a\u9032\u5ea6)<\/li>\n<li>\u53d6\u5f97\u8a8d\u5b9a\u5f8c\u53ef\u4eab\u6efe\u52d5\u5be9\u67e5\u3001\u512a\u5148\u5be9\u67e5\u7b49\u512a\u52e2,\u4f46\u9700\u7b26\u5408\u984d\u5916\u689d\u4ef6<\/li>\n<li>\u6642\u7a0b\u53d7\u75be\u75c5\u985e\u5225\u3001\u81e8\u5e8a\u6578\u64da\u5b8c\u6574\u6027\u3001FDA \u6e9d\u901a\u983b\u7387\u7b49\u56e0\u7d20\u5f71\u97ff<\/li>\n<li>\u53f0\u7063\u91ab\u85e5\u696d\u8005\u61c9\u63d0\u524d\u898f\u5283\u6642\u7a0b,\u907f\u514d\u8aa4\u89e3\u300c\u5feb\u901f\u901a\u9053 = \u5feb\u901f\u6838\u51c6\u300d<\/li>\n<\/ul>\n<p>\u82e5\u5c0d FDA \u85e5\u54c1\u5be9\u67e5\u5236\u5ea6\u8207\u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u4ecd\u6709\u7591\u554f,\u6b61\u8fce\u53c3\u8003 <a href=\"https:\/\/greenoo.tw\/zh\/\" target=\"_blank\" rel=\"noopener\">\u7da0\u5708\u5708\u5b98\u7db2<\/a> \u7684\u5c08\u696d\u9867\u554f\u670d\u52d9\u3002<\/p>\n<hr \/>\n<h2>\u53c3\u8003\u8cc7\u6599<\/h2>\n<p>\u672c\u6587\u5167\u5bb9\u57fa\u65bc\u4ee5\u4e0b FDA \u5b98\u65b9\u8cc7\u6599\u64b0\u5beb(\u622a\u81f3 2026 \u5e74 1 \u6708):<\/p>\n<ol>\n<li>U.S. Food and Drug Administration. &#8220;Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/patients\/fast-track-breakthrough-therapy-accelerated-approval-priority-review\/fast-track\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/patients\/fast-track-breakthrough-therapy-accelerated-approval-priority-review\/fast-track<\/a><\/li>\n<li>U.S. Food and Drug Administration. &#8220;Food and Drug Administration Safety and Innovation Act (FDASIA).&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/regulatory-information\/selected-amendments-fdc-act\/food-and-drug-administration-safety-and-innovation-act-fdasia\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/regulatory-information\/selected-amendments-fdc-act\/food-and-drug-administration-safety-and-innovation-act-fdasia<\/a><\/li>\n<li>Code of Federal Regulations Title 21, \u00a7 312.81. &#8220;Scope.&#8221; <em>eCFR<\/em>, <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-312.81\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ecfr.gov\/current\/title-21\/section-312.81<\/a><\/li>\n<\/ol>\n<p><em>\u8a3b:FDA \u6cd5\u898f\u53ef\u80fd\u66f4\u65b0,\u5efa\u8b70\u67e5\u95b1\u6700\u65b0\u5b98\u65b9\u6587\u4ef6\u6216\u8aee\u8a62\u5c08\u696d\u9867\u554f\u3002<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>FDA \u5feb\u901f\u901a\u9053\u8a8d\u5b9a\u7684\u300c\u5feb\u300d,\u6307\u7684\u4e0d\u662f\u6838\u51c6\u901f\u5ea6 \u6839\u64da FDA \u5feb\u901f\u901a\u9053\u8a08\u756b\u5b98\u65b9\u8aaa\u660e{:target=&#038;#822 [&hellip;]<\/p>","protected":false},"author":11,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[45],"tags":[],"class_list":["post-8128","post","type-post","status-publish","format-standard","hentry","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/8128"}],"collection":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/comments?post=8128"}],"version-history":[{"count":3,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/8128\/revisions"}],"predecessor-version":[{"id":20044,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/8128\/revisions\/20044"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=8128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=8128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=8128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}