{"id":1923,"date":"2024-12-17T15:53:34","date_gmt":"2024-12-17T07:53:34","guid":{"rendered":"https:\/\/www.vcro.com.tw\/tw\/?p=1923"},"modified":"2024-12-17T15:53:38","modified_gmt":"2024-12-17T07:53:38","slug":"%e8%88%87fda%e7%9a%84%e6%ad%a3%e5%bc%8f%e6%9c%83%e8%ad%b0%e8%a7%a3%e8%ae%80","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/tw\/?p=1923","title":{"rendered":"\u8207FDA\u7684\u6b63\u5f0f\u6703\u8b70\u89e3\u8b80"},"content":{"rendered":"\n

FDA\u8207\u7533\u8fa6\u65b9\u4e4b\u9593\u7684\u6703\u8b70\u5206\u70ba\u516d\u7a2e\u4e0d\u540c\u985e\u578b\uff0c\u65e8\u5728\u5354\u52a9\u63a8\u52d5\u7522\u54c1\u958b\u767c\u4e26\u63d0\u4f9b\u76e3\u7ba1\u5efa\u8b70\u3002
\u9019\u4e9b\u6703\u8b70\u6db5\u84cb\u7522\u54c1\u958b\u767c\u7684\u4e0d\u540c\u968e\u6bb5\u53ca\u9700\u6c42\uff0c\u4e26\u8a2d\u6709\u4e0d\u540c\u7684\u7533\u8acb\u689d\u4ef6\u8207\u6642\u7a0b\u898f\u5b9a\u3002 <\/p>\n\n\n\n

\u6703\u8b70\u985e\u578b<\/summary>\n
    \n
  1. A\u985e\u6703\u8b70
    A\u985e\u6703\u8b70\u9069\u7528\u65bc\u7522\u54c1\u958b\u767c\u53d7\u963b\u6216\u51fa\u73fe\u91cd\u5927\u5b89\u5168\u554f\u984c\u9700\u8981\u89e3\u6c7a\u7684\u60c5\u6cc1\u3002\u4f8b\u5982\uff0c\u722d\u8b70\u89e3\u6c7a\u6703\u8b70\u3001\u8a0e\u8ad6\u81e8\u5e8a\u66ab\u505c\u7684\u6703\u8b70\u3001FDA\u4e0d\u8a8d\u53ef\u7684\u7279\u6b8a\u65b9\u6848\u8a55\u4f30\u7d50\u679c\u7684\u6703\u8b70\uff0c\u6216\u5728\u6536\u5230\u4e0d\u6279\u51c6\u4fe1\u5f8c\u4e09\u500b\u6708\u5167\u7533\u8acb\u7684\u6703\u8b70\u3002A\u985e\u6703\u8b70\u7684\u7533\u8acb\u9700\u9644\u4e0aMeeting Package\uff0c\u4ee5\u4fbfFDA\u8a55\u4f30\u6703\u8b70\u7684\u5fc5\u8981\u6027\u3002 <\/li>\n\n\n\n
  2. B\u985e\u6703\u8b70
    B\u985e\u6703\u8b70\u6db5\u84cb\u7522\u54c1\u958b\u767c\u904e\u7a0b\u4e2d\u7684\u91cd\u8981\u91cc\u7a0b\u7891\u6703\u8b70\uff0c\u5305\u62ec\uff1a
    – \u524d\u671f\u65b0\u85e5\uff08pre-IND\uff09\u6703\u8b70
    – \u7dca\u6025\u6388\u6b0a\u524d\u6703\u8b70 
    – \u65b0\u85e5\u6216\u751f\u7269\u88fd\u54c1\u8a31\u53ef\u8b49\uff08pre-NDA\/BLA\uff09\u6703\u8b70 
    – \u91dd\u5c0d\u7a81\u7834\u6027\u7642\u6cd5\u6216\u518d\u751f\u91ab\u5b78\u5148\u9032\u7642\u6cd5\u7522\u54c1\u7684\u767c\u5c55\u8a08\u756b\u6703\u8b70<\/li>\n\n\n\n
  3. B\uff08EOP\uff09\u985e\u6703\u8b70
    B\uff08EOP\uff09\u985e\u6703\u8b70\u662f\u6307\u7279\u5b9a\u7684\u968e\u6bb5\u7d50\u675f\u6703\u8b70\uff0c\u4f8b\u5982\u7b2c\u4e00\u968e\u6bb5\u7d50\u675f\u6703\u8b70\uff08EOP1\uff09\u548c\u7b2c\u4e8c\u968e\u6bb5\u7d50\u675f\u6216\u7b2c\u4e09\u968e\u6bb5\u524d\u7684\u6703\u8b70\uff08EOP2\uff09\uff0c\u901a\u5e38\u91dd\u5c0d\u6709\u689d\u4ef6\u52a0\u901f\u6279\u51c6\u7684\u7522\u54c1\u6216\u5177\u6709\u7279\u6b8a\u7528\u9014\u7684\u7522\u54c1\u9032\u884c\u5be9\u67e5\u3002<\/li>\n\n\n\n
  4. C\u985e\u6703\u8b70
    C\u985e\u6703\u8b70\u9069\u7528\u65bc\u9664\u4e0a\u8ff0\u4ee5\u5916\u7684\u7522\u54c1\u958b\u767c\u53ca\u5be9\u67e5\u554f\u984c\uff0c\u4f8b\u5982\u5c31\u65b0\u66ff\u4ee3\u7d42\u9ede\u6a19\u8a18\u7684\u65e9\u671f\u8aee\u8a62\u6216FDA\u5728\u7279\u5b9a\u4f7f\u7528\u60c5\u5883\u4e2d\u5c0d\u5176\u9032\u884c\u9996\u6b21\u6279\u51c6\u7684\u610f\u898b\u3002<\/li>\n\n\n\n
  5. D\u985e\u6703\u8b70
    D\u985e\u6703\u8b70\u5c08\u6ce8\u65bc\u5c11\u6578\u7279\u5b9a\u8b70\u984c\uff0c\u901a\u5e38\u6d89\u53ca\u4e00\u5230\u5169\u500b\u554f\u984c\uff0c\u63d0\u4f9b\u95dc\u9375\u6027\u610f\u898b\u4ee5\u652f\u6301\u7522\u54c1\u958b\u767c\u3002\u4f8b\u5982\uff0c\u5728\u4e4b\u524d\u7684\u6b63\u5f0f\u6703\u8b70\u5f8c\u7684\u7279\u5b9a\u8ddf\u9032\u554f\u984c\uff0c\u6216\u6709\u95dc\u5275\u65b0\u958b\u767c\u65b9\u6cd5\u7684\u7c21\u55ae\u554f\u984c\u7b49\u3002<\/li>\n\n\n\n
  6. INTERACT\u6703\u8b70
    INTERACT\u6703\u8b70\u65e8\u5728\u652f\u6301\u65b0\u7a4e\u7684\u7522\u54c1\u548c\u958b\u767c\u8a08\u756b\uff0c\u89e3\u6c7a\u65e9\u671f\u958b\u767c\u4e2d\u9762\u81e8\u7684\u7368\u7279\u6311\u6230\uff0c\u901a\u5e38\u65bc\u63d0\u4ea4IND\u4e4b\u524d\u9032\u884c\u3002\u9019\u985e\u6703\u8b70\u591a\u6d89\u53ca\u6bd2\u7406\u5b78\u7814\u7a76\u3001\u8907\u96dc\u88fd\u9020\u6280\u8853\u3001\u5275\u65b0\u8a2d\u5099\u7684\u4f7f\u7528\u7b49\u554f\u984c\u3002<\/li>\n<\/ol>\n<\/details>\n\n\n\n
    \u6703\u8b70\u5f62\u5f0f<\/summary>\n

    \u6703\u8b70\u53ef\u4ee5\u63a1\u53d6\u4ee5\u4e0b\u56db\u7a2e\u5f62\u5f0f\uff1a 
    – \u9762\u5c0d\u9762\u6703\u8b70\uff1a\u53c3\u6703\u4eba\u54e1\u89aa\u81ea\u524d\u5f80FDA\uff0c\u4e26\u53ef\u8a2d\u6709\u865b\u64ec\u53c3\u8207\u8005
    – \u865b\u64ec\u9762\u5c0d\u9762\u6703\u8b70\uff1a\u6240\u6709\u53c3\u8207\u8005\u900f\u904e\u8996\u8a0a\u6703\u8b70\u5e73\u53f0\u9060\u7aef\u53c3\u52a0
    – \u96fb\u8a71\u6703\u8b70\uff1a\u50c5\u900f\u904e\u8a9e\u97f3\u901a\u8a71\u65b9\u5f0f\u9032\u884c\u6703\u8b70
    – \u66f8\u9762\u56de\u8986\uff08WRO\uff09\uff1a\u82e5\u6703\u8b70\u9700\u6c42\u53ef\u900f\u904e\u66f8\u9762\u56de\u8986\u89e3\u6c7a\uff0cFDA\u5c07\u9078\u64c7\u66f8\u9762\u5f62\u5f0f\u4f5c\u70ba\u66ff\u4ee3 <\/p>\n<\/details>\n\n\n\n

    \u6642\u7a0b\u5b89\u6392<\/summary>\n

    \u4e0d\u540c\u985e\u578b\u6703\u8b70\u7684\u7533\u8acb\u56de\u8986\u53ca\u53ec\u958b\u6642\u9650\u5982\u4e0b\uff1a 
    – A\u985e\u6703\u8b70\uff1a\u81ea\u6536\u5230\u7533\u8acb\u4e4b\u65e5\u8d7730\u5929\u5167\u53ec\u958b 
    – B\u985e\u6703\u8b70\uff1a60\u5929\u5167\u53ec\u958b
    – B\uff08EOP\uff09\u985e\u6703\u8b70\uff1a70\u5929\u5167\u53ec\u958b
    – C\u985e\u6703\u8b70\uff1a75\u5929\u5167\u53ec\u958b
    – D\u985e\u6703\u8b70\uff1a50\u5929\u5167\u53ec\u958b
    – INTERACT\u6703\u8b70\uff1a75\u5929\u5167\u53ec\u958b
    – \u66f8\u9762\u56de\u8986\u5247\u8207\u4e0a\u8ff0\u6703\u8b70\u5b89\u6392\u7684\u6642\u9650\u76f8\u540c<\/p>\n<\/details>\n\n\n\n

    \u6703\u8b70\u5f62\u5f0f\u7684\u6700\u7d42\u6c7a\u5b9a\u6b0a\u5728FDA\u624b\u4e2d\u3002\u96d6\u7136\u7533\u8fa6\u65b9\u53ef\u4ee5\u63d0\u51fa\u5e0c\u671b\u7684\u6703\u8b70\u5f62\u5f0f\uff08\u5982\u9762\u5c0d\u9762\u3001\u96fb\u8a71\u6703\u8b70\u6216\u66f8\u9762\u56de\u8986\uff09\uff0c\u4f46FDA\u5c07\u6839\u64da\u6703\u8b70\u9700\u6c42\u7684\u5177\u9ad4\u60c5\u6cc1\u4f86\u6c7a\u5b9a\u662f\u5426\u6279\u51c6\u8a72\u5f62\u5f0f\u3002 <\/p>\n\n\n\n

    \u5c0d\u65bc\u67d0\u4e9b\u6703\u8b70\uff08\u5982pre-IND\u3001C\u985e\u3001D\u985e\u548cINTERACT\u6703\u8b70\uff09\uff0c\u5373\u4f7f\u7533\u8fa6\u65b9\u8981\u6c42\u9762\u5c0d\u9762\u6216\u865b\u64ec\u6703\u8b70\uff0cFDA\u4e5f\u53ef\u80fd\u6c7a\u5b9a\u4ee5\u66f8\u9762\u56de\u8986\uff08WRO\uff09\u65b9\u5f0f\u63d0\u4f9b\u53cd\u994b\u3002\u5982\u679cFDA\u8a8d\u70ba\u66f8\u9762\u56de\u8986\u80fd\u66f4\u6709\u6548\u6eff\u8db3\u6703\u8b70\u9700\u6c42\uff0c\u5247\u6703\u901a\u77e5\u7533\u8fa6\u65b9\u9810\u8a08\u767c\u9001\u56de\u8986\u7684\u6642\u9593\u3002\u5982\u679c\u7533\u8fa6\u65b9\u4ecd\u8a8d\u70ba\u6709\u5fc5\u8981\u9032\u884c\u6703\u8b70\uff0c\u53ef\u4ee5\u63d0\u4f9b\u9032\u4e00\u6b65\u7406\u7531\uff0cFDA\u6703\u6839\u64da\u9019\u4e9b\u7406\u7531\u91cd\u65b0\u8003\u616e\u662f\u5426\u6539\u70ba\u53ec\u958b\u6703\u8b70\u3002 <\/p>\n\n\n\n

    \u6703\u8b70\u7684\u985e\u578b\uff0c\u4f8b\u5982Type D\uff0cINTERACT\u6703\u8b70\u7684\u539f\u5247\uff0c\u662f\u7531\u7533\u8fa6\u65b9\u9084\u662fFDA\u6c7a\u5b9a\u5462?<\/summary>\n

    \u6703\u8b70\u7684\u985e\u578b\u4e3b\u8981\u662f\u7531\u7533\u8fa6\u65b9\u63d0\u51fa\u7533\u8acb\u6642\u9078\u5b9a\uff0c\u4f46FDA\u5728\u5be9\u67e5\u7533\u8acb\u5f8c\u6709\u6b0a\u5c0d\u6703\u8b70\u985e\u578b\u9032\u884c\u8abf\u6574\u3002\u7533\u8fa6\u65b9\u6703\u6839\u64da\u958b\u767c\u9700\u6c42\uff0c\u91dd\u5c0d\u4e0d\u540c\u968e\u6bb5\u548c\u8b70\u984c\uff0c\u9078\u64c7\u9069\u5408\u7684\u6703\u8b70\u985e\u578b\uff08\u5982Type D\u6216INTERACT\u6703\u8b70\uff09\u9032\u884c\u7533\u8acb\u3002

    \u7136\u800c\uff0cFDA\u5728\u8a55\u4f30\u5f8c\u53ef\u80fd\u8a8d\u70ba\u53e6\u4e00\u985e\u578b\u7684\u6703\u8b70\u66f4\u70ba\u9069\u5408\uff0c\u5c24\u5176\u7576\u8b70\u984c\u8f03\u8907\u96dc\u6216\u6d89\u53ca\u591a\u500b\u5b78\u79d1\u6642\uff0cFDA\u6703\u901a\u77e5\u7533\u8fa6\u65b9\u8f49\u63db\u70ba\u66f4\u5408\u9069\u7684\u6703\u8b70\u985e\u578b\uff08\u5982\u5c07Type D\u6539\u70baType C\u6216Type B\u6703\u8b70\uff09\u3002<\/p>\n\n\n\n

    \u4f8b\u5982\uff0cType D\u6703\u8b70\u4e00\u822c\u9069\u7528\u65bc\u7bc4\u570d\u8f03\u7a84\u7684\u554f\u984c\uff0c\u82e5\u7533\u8fa6\u65b9\u63d0\u51fa\u7684\u554f\u984c\u904e\u591a\u6216\u904e\u65bc\u8907\u96dc\uff0cFDA\u53ef\u80fd\u5efa\u8b70\u8f49\u70baType C\u6703\u8b70\u3002\u6b64\u5916\uff0cINTERACT\u6703\u8b70\u901a\u5e38\u7528\u65bc\u7522\u54c1\u65e9\u671f\u958b\u767c\u968e\u6bb5\uff08\u5982IND\u63d0\u4ea4\u524d\uff09\uff0c\u82e5FDA\u8a8d\u70ba\u5176\u4ed6\u985e\u578b\u7684\u6703\u8b70\uff08\u5982Type B\u6703\u8b70\uff09\u66f4\u9069\u5408\u6642\uff0c\u4e5f\u6703\u9032\u884c\u8f49\u63db\u3002<\/p>\n<\/details>\n\n\n\n

    \u7dad\u5dde\u64c5\u9577\u904b\u7528\u6cd5\u898f\u5de5\u5177\u548c\u6642\u6a5f\u5354\u52a9\u5ba2\u6236\u52a0\u901f\u7522\u54c1\u958b\u767c\u9032\u7a0b\uff0c\u4e26\u7d50\u5408\u5be6\u969b\u8207\u5ba2\u6236\u5171\u540c\u660e\u78ba\u7814\u767c\u76ee\u6a19\uff0c\u5236\u5b9a\u5168\u9762\u7684\u7814\u767c\u8a3b\u518a\u8a08\u756b\u548c\u7b56\u7565\uff08\u4f8b\u5982\u5229\u7528\u8ddfFDA\u958b\u4e0d\u540c\u6703\u8b70\u7684\u6a5f\u6703\uff0c\u7528\u7dad\u5dde27\u5e74\u6253\u4ea4\u9053\u7684\u7d93\u9a57\u76e1\u91cf\u628a\u958b\u6703\u7d50\u679c\u5f80\u7533\u8fa6\u65b9\u6709\u5229\u7684\u65b9\u9762\u53bb\u6e96\u5099\uff09\u3002<\/p>\n\n\n\n

    \"VCRO<\/figure>\n\n\n\n

    Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry
    https:\/\/www.fda.gov\/media\/172311\/download<\/a><\/p>\n\n\n\n

    <\/p>\n","protected":false},"excerpt":{"rendered":"

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