{"id":1853,"date":"2025-04-01T17:16:29","date_gmt":"2025-04-01T09:16:29","guid":{"rendered":"https:\/\/www.vcro.com.tw\/cn\/?p=1853"},"modified":"2025-04-07T09:56:05","modified_gmt":"2025-04-07T01:56:05","slug":"%e7%be%8e%e5%9b%bdfda%e5%af%b9%e4%ba%8e%e4%b8%a5%e9%87%8d%e7%96%be%e7%97%85%e5%8a%a0%e9%80%9f%e8%ae%a1%e5%88%92-%e8%8d%af%e5%93%81%e6%9f%a5%e9%aa%8c%e7%99%bb%e8%ae%b0%e5%8a%a0%e9%80%9f%e6%a0%b8-2","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1853","title":{"rendered":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.)"},"content":{"rendered":"\n<ol start=\"3\" style=\"list-style-type:lower-alpha\" class=\"wp-block-list\">\n<li>\u52a0\u901f\u6838\u51c6\u4e4b\u8bc1\u636e\u6807\u51c6(Evidentiary Criteria for Accelerated Approval)\uff1a<br>\u6240\u6709\u83b7\u5f97\u52a0\u901f\u6838\u51c6\u7684\u836f\u54c1\u4ecd\u9700\u7b26\u5408FDA\u5bf9\u5b89\u5168\u6027\u4e0e\u6709\u6548\u6027\u7684\u5ba1\u6838\u6807\u51c6\uff0c\u8fd9\u5305\u62ec\u5382\u5546\u662f\u5426\u80fd\u63d0\u5177\u5145\u5206\u8bc1\u636e\uff0c\u8bc1\u660e\u6240\u63d0\u51fa\u7684\u66ff\u4ee3\u6307\u6807\u6216\u4e2d\u95f4\u4e34\u5e8a\u6307\u6807\u5177\u6709\u5408\u7406\u6027\uff0c\u4e14\u80fd\u6709\u6548\u9884\u6d4b\u836f\u54c1\u7684\u9884\u671f\u4e34\u5e8a\u6548\u76ca\u3002\u5728\u8bc4\u4f30\u6307\u6807\u662f\u5426\u80fd\u5408\u7406\u9884\u6d4b\u4e34\u5e8a\u6548\u76ca\u65f6\uff0cFDA\u4f1a\u7efc\u5408\u8003\u8651\u591a\u65b9\u7684\u8bc1\u636e\uff0c\u4f8b\u5982\u751f\u7269\u5b66\u673a\u5236\u3001\u6d41\u884c\u75c5\u5b66\u6570\u636e\u4ee5\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6570\u636e\u3002<\/li>\n<\/ol>\n\n\n\n<ol start=\"4\" style=\"list-style-type:lower-alpha\" class=\"wp-block-list\">\n<li>\u786e\u8ba4\u6027\u8bd5\u9a8c(Confirmatory Trials)\uff1a<br>FDA\u7684\u52a0\u901f\u6838\u51c6\u673a\u5236\u5141\u8bb8\u836f\u54c1\u5728\u663e\u793a\u6f5c\u5728\u6548\u76ca\u540e\u63d0\u524d\u4e0a\u5e02\uff0c\u4f46\u9700\u900f\u8fc7\u786e\u8ba4\u6027\u8bd5\u9a8c\u8bc1\u5b9e\u5176\u4e34\u5e8a\u6548\u76ca\u3002\u5382\u5546\u9700\u63d0\u4ea4\u8be6\u7ec6\u7684\u8bd5\u9a8c\u8ba1\u5212\u5e76\u6309\u65f6\u5b8c\u6210\u8bd5\u9a8c\uff0c\u82e5\u6838\u51c6\u65f6\u672a\u542f\u52a8\u8bd5\u9a8c\uff0c\u987b\u7acb\u5373\u5c55\u5f00\u3002\u5bf9\u4e8e\u7f55\u89c1\u75be\u75c5\u7b49\u7279\u6b8a\u60c5\u51b5\uff0c\u56e0\u53d7\u8bd5\u8005\u62db\u52df\u56f0\u96be\u800c\u65e0\u6cd5\u5b9e\u65bd\uff0cFDA\u53ef\u80fd\u91c7\u7528\u66ff\u4ee3\u65b9\u5f0f\u5b8c\u6210\u8bd5\u9a8c\uff0c\u4f8b\u5982\u5728\u5176\u4ed6\u76f8\u5173\u4f46\u4e0d\u540c\u7684\u75c5\u4eba\u7fa4\u4f53\u4e2d\u8fdb\u884c\u8bd5\u9a8c\uff0c\u6216\u57fa\u4e8e\u76f8\u540c\u7684\u66ff\u4ee3\u7ec8\u70b9\u8fdb\u884c\u66f4\u957f\u65f6\u95f4\u7684\u7814\u7a76\u3002\u6b64\u5916\uff0cFDA\u9f13\u52b1\u5382\u5546\u8003\u8651\u60a3\u8005\u9700\u6c42\uff0c\u63a8\u52a8\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u836f\u54c1\u7814\u53d1\uff0c\u4ee5\u786e\u4fdd\u6cbb\u7597\u66f4\u7b26\u5408\u5b9e\u9645\u9700\u6c42\u5e76\u63d0\u5347\u60a3\u8005\u53c2\u4e0e\u5ea6\u3002<\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg\" alt=\"VCRO \u7ef4\u5dde\u751f\u7269\u79d1\u6280 \u4ea7\u4e1a\u65b0\u8baf \u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.)\" class=\"wp-image-1858\" srcset=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg 1024w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2-300x300.jpg 300w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2-150x150.jpg 150w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2-768x768.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":1858,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[53,19,43,143,151,153,152,24,47,25,26,45,154],"class_list":["post-1853","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-11","tag-fda","tag-vcro","tag-43","tag-143","tag-151","tag-153","tag-152","tag-24","tag-47","tag-25","tag-26","tag-45","tag-154"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) - VCRO<\/title>\r\n<meta name=\"description\" content=\"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) VCRO \u4ea7\u4e1a\u65b0\u8baf - FDA\u7684\u52a0\u901f\u6838\u51c6\u673a\u5236\u5141\u8bb8\u836f\u54c1\u5728\u663e\u793a\u6f5c\u5728\u6548\u76ca\u540e\u63d0\u524d\u4e0a\u5e02\uff0c\u4f46\u9700\u900f\u8fc7\u786e\u8ba4\u6027\u8bd5\u9a8c\u8bc1\u5b9e\u5176\u4e34\u5e8a\u6548\u76ca\u3002\u5382\u5546\u9700\u63d0\u4ea4\u8be6\u7ec6\u7684\u8bd5\u9a8c\u8ba1\u5212\u5e76\u6309\u65f6\u5b8c\u6210\u8bd5\u9a8c\u3002\" \/>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.vcro.com.tw\/cn\/?p=1853\" \/>\r\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) - VCRO\" \/>\r\n<meta property=\"og:description\" content=\"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) VCRO \u4ea7\u4e1a\u65b0\u8baf - FDA\u7684\u52a0\u901f\u6838\u51c6\u673a\u5236\u5141\u8bb8\u836f\u54c1\u5728\u663e\u793a\u6f5c\u5728\u6548\u76ca\u540e\u63d0\u524d\u4e0a\u5e02\uff0c\u4f46\u9700\u900f\u8fc7\u786e\u8ba4\u6027\u8bd5\u9a8c\u8bc1\u5b9e\u5176\u4e34\u5e8a\u6548\u76ca\u3002\u5382\u5546\u9700\u63d0\u4ea4\u8be6\u7ec6\u7684\u8bd5\u9a8c\u8ba1\u5212\u5e76\u6309\u65f6\u5b8c\u6210\u8bd5\u9a8c\u3002\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.vcro.com.tw\/cn\/?p=1853\" \/>\r\n<meta property=\"og:site_name\" content=\"VCRO\" \/>\r\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/people\/\/100057388670681\/\" \/>\r\n<meta property=\"article:published_time\" content=\"2025-04-01T09:16:29+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2025-04-07T01:56:05+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1024\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"VCRO\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"VCRO\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 \u5206\" \/>\r\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853\"},\"author\":{\"name\":\"VCRO\",\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/#\/schema\/person\/2f08cc59b04b0a3bd4c58d32eb630c43\"},\"headline\":\"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.)\",\"datePublished\":\"2025-04-01T09:16:29+00:00\",\"dateModified\":\"2025-04-07T01:56:05+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853\"},\"wordCount\":17,\"publisher\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg\",\"keywords\":[\"FDA\",\"VCRO\",\"\u4e34\u5e8a\u8bd5\u9a8c\",\"\u52a0\u901f\u6838\u51c6\",\"\u6d41\u884c\u75c5\u5b66\",\"\u751f\u7269\u5b66\u673a\u5236\",\"\u786e\u8ba4\u6027\u8bd5\u9a8c\",\"\u7ef4\u5dde\",\"\u7ef4\u5dde\u751f\u6280\",\"\u7ef4\u5dde\u751f\u7269\",\"\u7ef4\u5dde\u751f\u7269\u79d1\u6280\",\"\u7ef4\u5dde\u751f\u7269\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8\",\"\u8bc1\u636e\u6807\u51c6\"],\"articleSection\":[\"\u4ea7\u4e1a\u65b0\u8baf\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853\",\"url\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853\",\"name\":\"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) - VCRO\",\"isPartOf\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg\",\"datePublished\":\"2025-04-01T09:16:29+00:00\",\"dateModified\":\"2025-04-07T01:56:05+00:00\",\"description\":\"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) VCRO \u4ea7\u4e1a\u65b0\u8baf - FDA\u7684\u52a0\u901f\u6838\u51c6\u673a\u5236\u5141\u8bb8\u836f\u54c1\u5728\u663e\u793a\u6f5c\u5728\u6548\u76ca\u540e\u63d0\u524d\u4e0a\u5e02\uff0c\u4f46\u9700\u900f\u8fc7\u786e\u8ba4\u6027\u8bd5\u9a8c\u8bc1\u5b9e\u5176\u4e34\u5e8a\u6548\u76ca\u3002\u5382\u5546\u9700\u63d0\u4ea4\u8be6\u7ec6\u7684\u8bd5\u9a8c\u8ba1\u5212\u5e76\u6309\u65f6\u5b8c\u6210\u8bd5\u9a8c\u3002\",\"breadcrumb\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853#breadcrumb\"},\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.vcro.com.tw\/cn\/?p=1853\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853#primaryimage\",\"url\":\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg\",\"contentUrl\":\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg\",\"width\":1024,\"height\":1024,\"caption\":\"VCRO \u7ef4\u5dde\u751f\u7269\u79d1\u6280 \u4ea7\u4e1a\u65b0\u8baf \u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.)\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/?p=1853#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u9996\u9875\",\"item\":\"https:\/\/www.vcro.com.tw\/cn\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/#website\",\"url\":\"https:\/\/www.vcro.com.tw\/cn\/\",\"name\":\"VCRO\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.vcro.com.tw\/cn\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/#organization\",\"name\":\"\u7ef4\u5dde\u80a1\u4efd\u6709\u9650\u516c\u53f8\",\"url\":\"https:\/\/www.vcro.com.tw\/cn\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/VCRO-logo-512-512-background-transparent.png\",\"contentUrl\":\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/VCRO-logo-512-512-background-transparent.png\",\"width\":512,\"height\":512,\"caption\":\"\u7ef4\u5dde\u80a1\u4efd\u6709\u9650\u516c\u53f8\"},\"image\":{\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/people\/\/100057388670681\/\",\"https:\/\/line.me\/R\/ti\/p\/277jsobo\",\"http:\/\/weixin.qq.com\/r\/eRD64tPE0I6vrZeB90Vr\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.vcro.com.tw\/cn\/#\/schema\/person\/2f08cc59b04b0a3bd4c58d32eb630c43\",\"name\":\"VCRO\",\"sameAs\":[\"https:\/\/www.vcro.com.tw\/cn\"],\"url\":\"https:\/\/www.vcro.com.tw\/cn\/?author=1\"}]}<\/script>\r\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) - VCRO","description":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) VCRO \u4ea7\u4e1a\u65b0\u8baf - FDA\u7684\u52a0\u901f\u6838\u51c6\u673a\u5236\u5141\u8bb8\u836f\u54c1\u5728\u663e\u793a\u6f5c\u5728\u6548\u76ca\u540e\u63d0\u524d\u4e0a\u5e02\uff0c\u4f46\u9700\u900f\u8fc7\u786e\u8ba4\u6027\u8bd5\u9a8c\u8bc1\u5b9e\u5176\u4e34\u5e8a\u6548\u76ca\u3002\u5382\u5546\u9700\u63d0\u4ea4\u8be6\u7ec6\u7684\u8bd5\u9a8c\u8ba1\u5212\u5e76\u6309\u65f6\u5b8c\u6210\u8bd5\u9a8c\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:\/\/www.vcro.com.tw\/cn\/?p=1853","og_locale":"zh_CN","og_type":"article","og_title":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) - VCRO","og_description":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) VCRO \u4ea7\u4e1a\u65b0\u8baf - FDA\u7684\u52a0\u901f\u6838\u51c6\u673a\u5236\u5141\u8bb8\u836f\u54c1\u5728\u663e\u793a\u6f5c\u5728\u6548\u76ca\u540e\u63d0\u524d\u4e0a\u5e02\uff0c\u4f46\u9700\u900f\u8fc7\u786e\u8ba4\u6027\u8bd5\u9a8c\u8bc1\u5b9e\u5176\u4e34\u5e8a\u6548\u76ca\u3002\u5382\u5546\u9700\u63d0\u4ea4\u8be6\u7ec6\u7684\u8bd5\u9a8c\u8ba1\u5212\u5e76\u6309\u65f6\u5b8c\u6210\u8bd5\u9a8c\u3002","og_url":"https:\/\/www.vcro.com.tw\/cn\/?p=1853","og_site_name":"VCRO","article_publisher":"https:\/\/www.facebook.com\/people\/\/100057388670681\/","article_published_time":"2025-04-01T09:16:29+00:00","article_modified_time":"2025-04-07T01:56:05+00:00","og_image":[{"width":1024,"height":1024,"url":"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg","type":"image\/jpeg"}],"author":"VCRO","twitter_card":"summary_large_image","twitter_misc":{"\u4f5c\u8005":"VCRO","\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4":"1 \u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853#article","isPartOf":{"@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853"},"author":{"name":"VCRO","@id":"https:\/\/www.vcro.com.tw\/cn\/#\/schema\/person\/2f08cc59b04b0a3bd4c58d32eb630c43"},"headline":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.)","datePublished":"2025-04-01T09:16:29+00:00","dateModified":"2025-04-07T01:56:05+00:00","mainEntityOfPage":{"@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853"},"wordCount":17,"publisher":{"@id":"https:\/\/www.vcro.com.tw\/cn\/#organization"},"image":{"@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853#primaryimage"},"thumbnailUrl":"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg","keywords":["FDA","VCRO","\u4e34\u5e8a\u8bd5\u9a8c","\u52a0\u901f\u6838\u51c6","\u6d41\u884c\u75c5\u5b66","\u751f\u7269\u5b66\u673a\u5236","\u786e\u8ba4\u6027\u8bd5\u9a8c","\u7ef4\u5dde","\u7ef4\u5dde\u751f\u6280","\u7ef4\u5dde\u751f\u7269","\u7ef4\u5dde\u751f\u7269\u79d1\u6280","\u7ef4\u5dde\u751f\u7269\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8","\u8bc1\u636e\u6807\u51c6"],"articleSection":["\u4ea7\u4e1a\u65b0\u8baf"],"inLanguage":"zh-Hans"},{"@type":"WebPage","@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853","url":"https:\/\/www.vcro.com.tw\/cn\/?p=1853","name":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) - VCRO","isPartOf":{"@id":"https:\/\/www.vcro.com.tw\/cn\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853#primaryimage"},"image":{"@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853#primaryimage"},"thumbnailUrl":"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg","datePublished":"2025-04-01T09:16:29+00:00","dateModified":"2025-04-07T01:56:05+00:00","description":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.) VCRO \u4ea7\u4e1a\u65b0\u8baf - FDA\u7684\u52a0\u901f\u6838\u51c6\u673a\u5236\u5141\u8bb8\u836f\u54c1\u5728\u663e\u793a\u6f5c\u5728\u6548\u76ca\u540e\u63d0\u524d\u4e0a\u5e02\uff0c\u4f46\u9700\u900f\u8fc7\u786e\u8ba4\u6027\u8bd5\u9a8c\u8bc1\u5b9e\u5176\u4e34\u5e8a\u6548\u76ca\u3002\u5382\u5546\u9700\u63d0\u4ea4\u8be6\u7ec6\u7684\u8bd5\u9a8c\u8ba1\u5212\u5e76\u6309\u65f6\u5b8c\u6210\u8bd5\u9a8c\u3002","breadcrumb":{"@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853#breadcrumb"},"inLanguage":"zh-Hans","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.vcro.com.tw\/cn\/?p=1853"]}]},{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853#primaryimage","url":"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg","contentUrl":"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2025\/04\/\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6-Accelerated-Approval\u53d1\u5e03\u6307\u5f15\u8349\u6848-Part-2.jpg","width":1024,"height":1024,"caption":"VCRO \u7ef4\u5dde\u751f\u7269\u79d1\u6280 \u4ea7\u4e1a\u65b0\u8baf \u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.)"},{"@type":"BreadcrumbList","@id":"https:\/\/www.vcro.com.tw\/cn\/?p=1853#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"\u9996\u9875","item":"https:\/\/www.vcro.com.tw\/cn\/"},{"@type":"ListItem","position":2,"name":"\u7f8e\u56fdFDA\u5bf9\u4e8e\u4e25\u91cd\u75be\u75c5\u52a0\u901f\u8ba1\u5212-\u836f\u54c1\u67e5\u9a8c\u767b\u8bb0\u52a0\u901f\u6838\u51c6 (Accelerated Approval)\u53d1\u5e03\u6307\u5f15\u8349\u6848 (Part 2.)"}]},{"@type":"WebSite","@id":"https:\/\/www.vcro.com.tw\/cn\/#website","url":"https:\/\/www.vcro.com.tw\/cn\/","name":"VCRO","description":"","publisher":{"@id":"https:\/\/www.vcro.com.tw\/cn\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.vcro.com.tw\/cn\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-Hans"},{"@type":"Organization","@id":"https:\/\/www.vcro.com.tw\/cn\/#organization","name":"\u7ef4\u5dde\u80a1\u4efd\u6709\u9650\u516c\u53f8","url":"https:\/\/www.vcro.com.tw\/cn\/","logo":{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/www.vcro.com.tw\/cn\/#\/schema\/logo\/image\/","url":"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/VCRO-logo-512-512-background-transparent.png","contentUrl":"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/VCRO-logo-512-512-background-transparent.png","width":512,"height":512,"caption":"\u7ef4\u5dde\u80a1\u4efd\u6709\u9650\u516c\u53f8"},"image":{"@id":"https:\/\/www.vcro.com.tw\/cn\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/people\/\/100057388670681\/","https:\/\/line.me\/R\/ti\/p\/277jsobo","http:\/\/weixin.qq.com\/r\/eRD64tPE0I6vrZeB90Vr"]},{"@type":"Person","@id":"https:\/\/www.vcro.com.tw\/cn\/#\/schema\/person\/2f08cc59b04b0a3bd4c58d32eb630c43","name":"VCRO","sameAs":["https:\/\/www.vcro.com.tw\/cn"],"url":"https:\/\/www.vcro.com.tw\/cn\/?author=1"}]}},"_links":{"self":[{"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=\/wp\/v2\/posts\/1853","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1853"}],"version-history":[{"count":3,"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=\/wp\/v2\/posts\/1853\/revisions"}],"predecessor-version":[{"id":1859,"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=\/wp\/v2\/posts\/1853\/revisions\/1859"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=\/wp\/v2\/media\/1858"}],"wp:attachment":[{"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1853"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1853"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.vcro.com.tw\/cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1853"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}