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23:15","asker":"cninfo616294","answer":"\u7ff0\u5b87\u836f\u4e1a","question":"\u60a8\u597d\uff01\u8d35\u53f8\u5927\u5065\u5eb7\u4ea7\u54c1\u662f\u5426\u6709\u53d6\u5f97\u65b0\u7684\u8fdb\u5c55\uff0c\u8d35\u53f8\u6709\u8bf7\u660e\u661f\u4ee3\u8a00\u5417\uff1f","reply":"\u7b54\uff1a\u6211\u53f8\u6d88\u8d39\u7c7b\u65b0\u4ea7\u54c1-\u201c\u7ff0\u8212\u201d\u5927\u9cb5\u9aa8\u80f6\u539f\u86cb\u767d\u80bd\uff0c\u65b0\u54c1\u4e0a\u5e02\u53d1\u5e03\u4f1a\u4eca\u65e5\u4e8e\u6df1\u5733\u4e3e\u884c\uff0c\u5e7f\u5927\u6d88\u8d39\u8005\u53ef\u901a\u8fc7\u68c0\u7d22\u5546\u54c1\u5173\u952e\u8bcd\uff0c\u5728\u6dd8\u5b9d\u4e0b\u5355\u8d2d\u4e70\u3002\u7ff0\u5b87\u5df2\u7ecf\u4e0a\u5e02\u7684\u5927\u5065\u5eb7\u4ea7\u54c1\u5305\u62ec\uff1aHY3000\u4e13\u5229\u76f8\u5173\u5927\u6d88\u8d39\u7c7b\u4ea7\u54c1\u201c\u7ff0\u536b\u201d\u3001\u201c\u7ff0\u62a4\u201d\u878d\u5408\u6291\u5236\u80bd\u9632\u62a4\u55b7\u96fe\u5242\u3001\u7761\u7720\u7528\u201c\u6b23\u7720\u201d\u3001\u201c\u5bfb\u7720\u201d\u4e24\u6b3e\u916a\u86cb\u767d\u751f\u7269\u6d3b\u6027\u80bd\u3001\u4ee5\u53ca\u201c\u535a\u8212\u598d\u201d\u7cfb\u5217\u62a4\u80a4\u54c1\u3001\u4e2a\u4eba\u536b\u751f\u62a4\u7406\u7c7b\u4ea7\u54c1\u7b49\uff0c\u5728\u4eac\u4e1c\u5546\u57ce\u3001\u6709\u8d5e\u5546\u94fa\u3001\u5c0f\u7ea2\u4e66\u3001\u6296\u97f3\u7b49\u5e73\u53f0\u68c0\u7d22\u4ea7\u54c1\u5173\u952e\u8bcd\u53ef\u4e0b\u5355\u8d2d\u4e70\u3002\u672a\u6765\u8fd8\u5e03\u5c40\u6709\u51cf\u91cd\u3001\u89e3\u9152\u62a4\u809d\u7b49\u591a\u80bd\u5927\u5065\u5eb7\u7c7b\u4ea7\u54c1\u3002","type":1,"publishsource":"\u6df1\u4ea4\u6240\u4e92\u52a8\u6613","resource":1},{"year":"2024","month":"03","day":"13 18:11","asker":"irm3485860","answer":"\u7ff0\u5b87\u836f\u4e1a","question":"\u8463\u79d8\u60a8\u597d\uff0c\u8bf7\u95ee\u662f\u5426\u6709\u5728\u4e0e\u5176\u4ed6\u6d77\u5916\u516c\u53f8\u63a5\u6d3d\u5546\u8c08\u4f9b\u8d27\u4e8b\u5b9c\uff1f","reply":"\u78a7\u8fea\u533b\u7597\uff08BDX\uff09\u4e8e3\u670812\u65e5\u5230\u8bbf\u7ff0\u5b87\u836f\u4e1a\uff0c\u53cc\u65b9\u56f4\u7ed5\u201c\u5171\u540c\u52a0\u901f\u591a\u80bd\u836f\u7269\u56fd\u9645\u5316\u8fdb\u7a0b\u201d\u4e3b\u9898\uff0c\u5c55\u5f00\u4e86\u6df1\u5ea6\u63a2\u8ba8\uff0c\u5185\u5bb9\u6d89\u53ca\u7ff0\u5b87\u836f\u4e1a\u5229\u62c9\u9c81\u80bd\u6ce8\u5c04\u5242\u4ea7\u54c1\u7f8e\u56fd\u5e02\u573a\u5546\u4e1a\u5316\u5907\u8d27\u6240\u9700\u7684\u6ce8\u5c04\u7b14\u4f9b\u5e94\u4fdd\u969c\uff0c\u4ee5\u53ca\u53f8\u7f8e\u683c\u9c81\u80bd\u7b49\u672a\u6765GLP-1\u4ea7\u54c1\u7684\u5408\u4f5c\u89c4\u5212\u3002\u78a7\u8fea\u533b\u7597\u6210\u7acb\u4e8e1897\u5e74\uff0c\u662f\u5168\u7403\u77e5\u540d\u7684\u533b\u7597\u5668\u68b0\u521b\u65b0\u516c\u53f8\uff0c\u5728\u5404\u56fd\u5747\u8bbe\u6709\u5206\u652f\u673a\u6784\u3002","type":1,"publishsource":"\u6df1\u4ea4\u6240\u4e92\u52a8\u6613","resource":1},{"year":"2024","month":"03","day":"05 18:49","asker":"irm118878764","answer":"\u7ff0\u5b87\u836f\u4e1a","question":"\u8d35\u516c\u53f8FDA\u8bc1\u4e66\u8fdb\u5ea6\u5982\u4f55\uff1f\u9884\u8ba1\u4ec0\u4e48\u65f6\u5019\u80fd\u62ff\u5230\u8bc1\uff1f","reply":"3\u67084\u65e5\uff0c\u7ff0\u5b87\u836f\u4e1a\u6536\u5230\u4e86\u7f8e\u56fdFDA\u4e0b\u53d1\u7684\u5229\u62c9\u9c81\u80bd\u539f\u6599\u836f\u300aFirst Adequate Letter\u300b\uff0c\u8be5\u4fe1\u51fd\u8868\u660e\u7ff0\u5b87\u836f\u4e1a\u751f\u4ea7\u7684\u5229\u62c9\u9c81\u80bd\u539f\u6599\u836f\u672c\u8f6ereview cycle\u5ba1\u8bc4\u9636\u6bb5\u5df2\u7ed3\u675f\uff0c\u5e76\u901a\u8fc7\u4e86\u6280\u672f\u5ba1\u8bc4\uff0c\u8d28\u91cf\u83b7\u5f97\u4e86\u7f8e\u56fdFDA\u7684\u8ba4\u53ef\uff0c\u6ee1\u8db3\u5f53\u524d\u4e24\u5bb6\u5173\u8054\u5236\u5242\u5ba2\u6237ANDA\u7684\u5ba1\u8bc4\u8981\u6c42\u3002\u53e6\u5916\uff0c\u516c\u53f8\u4e5f\u5df2\u6536\u5230\u4e86\u7f8e\u56fdFDA\u5173\u4e8e\u5229\u62c9\u9c81\u80bd\u539f\u6599\u836fDMF\u7684No further 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18:49","asker":"cninfo1171899","answer":"\u7ff0\u5b87\u836f\u4e1a","question":"\u5c0a\u656c\u7684\u8463\u79d8\uff0c\u54b1\u7684FDA\u8fdb\u884c\u5230\u4ec0\u4e48\u7a0b\u5ea6\u4e86","reply":"3\u67084\u65e5\uff0c\u7ff0\u5b87\u836f\u4e1a\u6536\u5230\u4e86\u7f8e\u56fdFDA\u4e0b\u53d1\u7684\u5229\u62c9\u9c81\u80bd\u539f\u6599\u836f\u300aFirst Adequate Letter\u300b\uff0c\u8be5\u4fe1\u51fd\u8868\u660e\u7ff0\u5b87\u836f\u4e1a\u751f\u4ea7\u7684\u5229\u62c9\u9c81\u80bd\u539f\u6599\u836f\u672c\u8f6ereview cycle\u5ba1\u8bc4\u9636\u6bb5\u5df2\u7ed3\u675f\uff0c\u5e76\u901a\u8fc7\u4e86\u6280\u672f\u5ba1\u8bc4\uff0c\u8d28\u91cf\u83b7\u5f97\u4e86\u7f8e\u56fdFDA\u7684\u8ba4\u53ef\uff0c\u6ee1\u8db3\u5f53\u524d\u4e24\u5bb6\u5173\u8054\u5236\u5242\u5ba2\u6237ANDA\u7684\u5ba1\u8bc4\u8981\u6c42\u3002\u53e6\u5916\uff0c\u516c\u53f8\u4e5f\u5df2\u6536\u5230\u4e86\u7f8e\u56fdFDA\u5173\u4e8e\u5229\u62c9\u9c81\u80bd\u539f\u6599\u836fDMF\u7684No further comments\u90ae\u4ef6\u901a\u77e5\uff0c\u83b7\u5f97no 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