{"id":1861,"date":"2025-04-10T14:38:59","date_gmt":"2025-04-10T06:38:59","guid":{"rendered":"https:\/\/www.vcro.com.tw\/cn\/?p=1861"},"modified":"2025-04-10T14:39:00","modified_gmt":"2025-04-10T06:39:00","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%b8-3","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/cn\/?p=1861","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 3.)"},"content":{"rendered":"\n
    \n
  1. \u5176\u4ed6\u989d\u5916\u7684\u8981\u6c42\uff1a<\/li>\n<\/ol>\n\n\n\n
      \n
    1. \u4fe1\u606f\u900f\u660e\u6027\uff1a\u6839\u636e\u6307\u5f15\uff0c\u6240\u6709\u83b7\u5f97\u52a0\u901f\u6838\u51c6\u7684\u836f\u54c1\uff0c\u5176\u836f\u54c1\u4eff\u5355\u4e2d\u9002\u5e94\u75c7\u76f8\u5173\u6bb5\u843d\u9700\u6e05\u695a\u8bf4\u660e\u4f7f\u7528\u9650\u5236\u53ca\u6f5c\u5728\u4e34\u5e8a\u6548\u76ca\u7684\u4e0d\u786e\u5b9a\u6027\uff0c\u5e76\u6307\u51faFDA\u7684\u6279\u51c6\u662f\u57fa\u4e8e\u52a0\u901f\u6838\u51c6\u7ba1\u9053\u7684\u58f0\u660e\u3002\u8fd9\u4e00\u8981\u6c42\u65e8\u5728\u63d0\u9ad8\u4fe1\u606f\u900f\u660e\u5ea6\uff0c\u8ba9\u60a3\u8005\u5728\u4f7f\u7528\u8fd9\u4e9b\u7ecf\u7279\u6b8a\u5ba1\u6838\u7684\u836f\u54c1\u65f6\uff0c\u80fd\u591f\u4e86\u89e3\u5176\u6f5c\u5728\u98ce\u9669\u4e0e\u6548\u76ca\u3002<\/li>\n\n\n\n
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    3. \u786e\u8ba4\u6027\u8bd5\u9a8c\u7684\u8fdb\u5ea6\u66f4\u65b0\uff1a\u5382\u5546\u9700\u5b9a\u671f\u63d0\u4ea4\u62a5\u544a\uff0c\u66f4\u65b0\u786e\u8ba4\u6027\u8bd5\u9a8c\u7684\u8fdb\u5c55\u60c5\u51b5\uff0c\u786e\u4fdd\u8bd5\u9a8c\u80fd\u6309\u89c4\u5212\u8fdb\u884c\u3002<\/li>\n<\/ol>\n\n\n\n
        \n
      1. \u64a4\u9500\u6838\u51c6\u7684\u7a0b\u5e8f(Withdrawal of Accelerated Approval)\uff1a
        \u5982\u679c\u786e\u8ba4\u6027\u8bd5\u9a8c\u672a\u80fd\u9a8c\u8bc1\u836f\u54c1\u7684\u4e34\u5e8a\u6548\u76ca\uff0c\u6216\u5382\u5546\u672a\u6309\u65f6\u5b8c\u6210\u8bd5\u9a8c\uff0c\u6216\u6709\u65b0\u7684\u5b89\u5168\u6027\u6216\u6709\u6548\u6027\u95ee\u9898\uff0c\u751a\u81f3\u82e5\u5382\u5546\u6563\u5e03\u865a\u5047\u5ba3\u4f20\u6570\u636e\uff0cFDA\u53ef\u542f\u52a8\u52a0\u901f\u6838\u51c6\u64a4\u9500\u7a0b\u5e8f\uff0c\u5305\u62ec\uff1a\u901a\u77e5\u5382\u5546\u3001\u63d0\u4f9b\u64a4\u56de\u89e3\u91ca\u3001\u516c\u5f00\u5f81\u6c42\u610f\u89c1\u3001\u4e0e\u5382\u5546\u4f1a\u8bae\u4ee5\u53ca\u53ec\u5f00\u4e13\u5bb6\u54a8\u8be2\u59d4\u5458\u4f1a\u7b49\u6b65\u9aa4\uff0c\u786e\u4fdd\u7a0b\u5e8f\u516c\u5e73\u4e0e\u900f\u660e\u3002\u6b64\u5916\uff0cFDA\u5c06\u5c31\u64a4\u56de\u63d0\u8bae\u5f81\u6c42\u516c\u4f17\u610f\u89c1\u5e76\u5728\u7f51\u7ad9\u53d1\u5e03\u8be5\u610f\u89c1\u6458\u8981\u53ca\u5176\u54cd\u5e94\u3002<\/li>\n<\/ol>\n\n\n\n

        \u603b\u7ed3<\/strong>
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        \u5ef6\u4f38\u9605\u8bfb<\/strong>
        U.S. FDA. Expedited Program for Serious Conditions\uff0dAccelerated Approval of Drugs and Biologics. (Draft Guidance) Dec. 2024<\/p>\n\n\n\n

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