{"id":57015,"date":"2018-09-27T01:00:00","date_gmt":"2018-09-30T02:21:59","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/fda-%e7%9f%a5%e8%af%86%e8%be%85%e5%8a%a9%e8%af%84%e4%bc%b0%e5%92%8c%e7%bb%93%e6%9e%84%e5%8c%96%e7%94%b3%e8%af%b7%e8%ae%a1%e5%88%92%e6%8f%90%e4%b8%8a%e8%ae%ae%e7%a8%8b\/"},"modified":"2018-09-30T10:22:01","modified_gmt":"2018-09-30T02:22:01","slug":"fda-%e7%9f%a5%e8%af%86%e8%be%85%e5%8a%a9%e8%af%84%e4%bc%b0%e5%92%8c%e7%bb%93%e6%9e%84%e5%8c%96%e7%94%b3%e8%af%b7%e8%ae%a1%e5%88%92%e6%8f%90%e4%b8%8a%e8%ae%ae%e7%a8%8b","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/57015\/","title":{"rendered":"FDA \u77e5\u8bc6\u8f85\u52a9\u8bc4\u4f30\u548c\u7ed3\u6784\u5316\u7533\u8bf7\u8ba1\u5212\u63d0\u4e0a\u8bae\u7a0b"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\" ><span style=\"font-size: 16px;\">\u7f8e\u56fd FDA \u4e8e 9 \u6708 20 \u65e5\u53ec\u5f00\u836f\u54c1\u79d1\u5b66\u548c\u4e34\u5e8a\u836f\u7406\u5b66\u54a8\u8be2\u59d4\u5458\u4f1a\u4f1a\u8bae\uff0c\u8ba8\u8bba FDA \u77e5\u8bc6\u8f85\u52a9\u8bc4\u4f30\u548c\u7ed3\u6784\u5316\u7533\u8bf7\uff08KASA\uff09\u7684\u5b9e\u65bd\u8ba1\u5212\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u5982 FDA \u5c40\u957f Scott Gottlieb \u5728\u516d\u6708\u4efd\u535a\u5ba2\u4e2d\u8bf4\u7684\u90a3\u6837\uff0cKASA \u5e73\u53f0\u65e8\u5728\u5c06\u4eff\u5236\u836f\u5ba1\u8bc4\u4ece\u57fa\u4e8e\u6587\u672c\u7684\u8bc4\u4f30\u73b0\u4ee3\u5316\u4e3a\u57fa\u4e8e\u6570\u636e\u7684\u8bc4\u4f30\u3002\u4f46\u5468\u56db\u7684\u8ba8\u8bba\u6e05\u695a\u7684\u8868\u660e\uff0cKASA \u7cfb\u7edf\u4e5f\u53ef\u4ee5\u6269\u5c55\u7528\u4e8e\u65b0\u836f\u7533\u8bf7\u751a\u81f3\u662f\u751f\u7269\u5236\u5242\u8bb8\u53ef\u7533\u8bf7\u3002<a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzA5MDAyNjQxMw==&amp;mid=2650389953&amp;idx=1&amp;sn=f87fd2e4af3d1497f72bbd9d547892a8&amp;chksm=881ce503bf6b6c151f55a46e036c09684913ed0493e90ed552ddba14fc21c0dd264ebc1802d8&amp;scene=21#wechat_redirect\" target=\"_blank\" style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;\"><span style=\"text-decoration: underline;font-size: 16px;\">\u3010FDA \u5c40\u957f\u8c08\u4eff\u5236\u836f\u5ba1\u8bc4\u4e0e\u77e5\u8bc6\u7ba1\u7406 2018\/06\/20\u3011<\/span><\/a><\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">FDA \u5411\u54a8\u8be2\u59d4\u5458\u4f1a\u63d0\u4ea4 KASA \u8ba1\u5212\u7684\u4e24\u4e2a\u4e3b\u8981\u76ee\u6807\u3002\u4e00\u65b9\u9762\uff0c\u901a\u8fc7\u7533\u8bf7\u4eba\u5728\u7533\u8bf7\u4e2d\u7528\u4e8e\u8bb0\u5f55\u836f\u54c1\u7814\u53d1\u3001\u751f\u4ea7\u548c\u4ea7\u54c1\u8d28\u91cf\u4fe1\u606f\u7684\u6807\u51c6\u5316\u6a21\u677f\uff0c\u66f4\u9ad8\u6548\u7684\u5ba1\u8bc4 NDA\u3001ANDA \u548c BLA \u7684 CMC \u90e8\u5206\u3002\u671f\u671b\u662f\uff0c\u5982\u679c\u4ece\u4e00\u4ef6\u7533\u8bf7\u5230\u53e6\u4e00\u4ef6\u7533\u8bf7\u5747\u4ee5\u4e00\u81f4\u7684\u683c\u5f0f\u63d0\u4f9b CMC \u4fe1\u606f\uff0c\u5219\u5ba1\u8bc4\u4eba\u5458\u5c06\u80fd\u591f\u5feb\u901f\u67e5\u627e\u548c\u8bc4\u4f30\u4fe1\u606f\u3002KASA \u7684\u7b2c\u4e8c\u4e2a\u76ee\u6807\u662f\u5141\u8bb8 FDA \u5c06\u5176\u63a5\u6536\u548c\u5ba1\u8bc4\u7684\u4f17\u591a\u7533\u8bf7\u4e2d\u7684\u4fe1\u606f\u6293\u53d6\u5230\u81ea\u5df1\u7684\u6570\u636e\u5e93\u4e2d\u3002\u6b64\u7c7b\u4fe1\u606f\uff08\u4f8b\u5982\uff0c\u89c4\u683c\u3001\u7a33\u5b9a\u6027\u6570\u636e\u3001\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u548c\u5173\u952e\u5de5\u827a\u53c2\u6570\uff09\u7684\u5e7f\u6cdb\u6570\u636e\u5e93\u53ef\u88ab\u7528\u4e8e\u6269\u5c55\u751f\u4ea7\u548c\u4ea7\u54c1\u8d28\u91cf\u7684\u77e5\u8bc6\u5e93\uff0c\u4ece\u800c\u4f7f FDA \u80fd\u591f\u66f4\u5ba2\u89c2\u5730\u8bc4\u4f30\u4ea7\u54c1\u8d28\u91cf\u548c\u6027\u80fd\u7684\u98ce\u9669\u3002\u76ee\u524d\uff0c\u867d\u7136\u7533\u8bf7\u9075\u5faa\u57fa\u672c eCTD \u683c\u5f0f\uff0c\u4f46\u63d0\u4ea4\u7684\u4fe1\u606f\u662f\u975e\u7ed3\u6784\u5316\u6587\u672c\uff0c\u5fc5\u987b\u624b\u52a8\u8f93\u5165\u6570\u636e\u5e93\uff0c\u8fd9\u4e00\u8fc7\u7a0b\u4ee3\u4ef7\u6781\u4e3a\u9ad8\u6602\u4e14\u8d44\u6e90\u5bc6\u96c6\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">FDA \u836f\u54c1\u8d28\u91cf\u529e\u516c\u5ba4\uff08OPQ\uff09\u7684Larisa Wu \u8fdb\u4e00\u6b65\u8ba8\u8bba\u4e86\u5411 KASA \u8f6c\u53d8\u7684\u76ee\u6807\uff0c\u5e76\u6307\u51fa\uff0c\u9664\u5176\u5b83\u4f18\u52bf\u5916\uff0cKASA \u6709\u52a9\u4e8e\u6279\u51c6\u540e\u53d8\u66f4\u7684\u8bc4\u4f30\u4ee5\u53ca\u836f\u54c1\u7684\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002Wu \u8fd8\u6307\u51fa\u4e86 FDA \u76ee\u524d\u4f7f\u7528\u7684 eCTD 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style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u4f1a\u8bae\u671f\u95f4\uff0cFDA \u627f\u8ba4\u5168\u9762\u5b9e\u65bdKASA \u8ba1\u5212\u9700\u8981\u65f6\u95f4\u3002\u9700\u8981\u5efa\u7acb\u7533\u8bf7\u4eba\u5c06\u53ef\u4ee5\u4ece\u4e2d\u9009\u62e9\u7684\u5408\u9002\u7684\u6807\u51c6\u5316\u6570\u636e\u5b57\u6bb5\uff0c\u5f00\u53d1\u7528\u4e8e\u6293\u53d6\u6570\u636e\u7684\u8ba1\u7b97\u673a\u5316\u7528\u6237\u754c\u9762\uff0c\u4ee5\u53ca\u5236\u5b9a\u884c\u4e1a\u6307\u5357\u548c\u57f9\u8bad\u3002\u5c3d\u7ba1\u9762\u4e34\u8fd9\u4e9b\u6311\u6218\uff0c\u54a8\u8be2\u59d4\u5458\u4f1a\u6210\u5458\u4ecd\u4e00\u81f4\u652f\u6301 FDA \u63a8\u8fdb\u8fd9\u4e00\u4e3e\u63aa\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u76ee\u524d\uff0cFDA \u8ba1\u5212\u5728 2019 \u5e74\u201c\u8f6f\u201d\u63a8\u51fa KASA\uff0c\u65b0\u7684\u7ed3\u6784\u5316\u7533\u8bf7\u683c\u5f0f\u5c06\u662f\u81ea\u613f\u7684\u3002\u4eba\u4eec\u53ef\u4ee5\u4ece\u8fd9\u91cc\u770b\u51fa\uff0c\u5728\u67d0\u4e2a\u7279\u5b9a\u7684\u65f6\u95f4\u70b9\uff0cKASA \u683c\u5f0f\u5c06\u6210\u4e3a\u5f3a\u5236\u6027\u7684\u3002\u56e0\u6b64\uff0cFDA \u8868\u793a\u6b63\u5728\u6839\u636e\u300a\u8054\u90a6\u98df\u54c1\u3001\u836f\u54c1\u548c\u5316\u5986\u54c1\u6cd5\u6848\u300b\u7b2c 745A \u8282\u7684\u89c4\u5b9a\u5236\u5b9a\u5173\u4e8e\u4ee5 FDA \u6307\u5b9a\u7684\u7535\u5b50\u683c\u5f0f\u5411 FDA \u63d0\u4ea4\u4fe1\u606f\u7684\u8981\u6c42\u3002\u6700\u7ec8\u63a8\u51fa\u7684\u987a\u5e8f\u6709\u53ef\u80fd\u9996\u5148\u662f ANDA\uff0c\u7136\u540e\u662f NDA\uff0c\u6700\u540e\u662f BLA\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u9664\u4e86\u5bf9 KASA \u7684\u575a\u5b9a\u652f\u6301\u5916\uff0c\u59d4\u5458\u4f1a\u8fd8\u5411 FDA \u63d0\u4e86\u4ee5\u4e0b\u5efa\u8bae\uff1a<br  \/>\u2022\t\u786e\u4fdd KASA \u6293\u53d6\u7684\u6570\u636e\u53ef\u4ee5\u5bfc\u51fa\uff0c\u4ee5\u4f9b\u5176\u5b83\u6570\u636e\u5206\u6790\u7a0b\u5e8f\u5206\u6790\u3002<br  \/>\u2022\t\u786e\u4fdd\u6570\u636e\u5b57\u6bb5\u53ef\u4ee5\u66f4\u65b0\u6dfb\u52a0\u65b0\u9009\u9879\u3002<br  \/>\u2022\t\u8003\u8651\u5c06\u901a\u8fc7 KASA \u83b7\u5f97\u7684\u77e5\u8bc6\u56de\u9988\u7ed9\u4e1a\u754c\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u8be5\u8ba1\u5212\u53ef\u4ee5\u4ece\u5ba1\u8bc4\u8fc7\u7a0b\u4e2d\u53bb\u9664\u4e00\u4e9b\u4e3b\u89c2\u8bc4\u4ef7\uff0c\u4ece\u884c\u4e1a\u89d2\u5ea6\u6765\u770b\uff0c\u8fd9\u53ef\u80fd\u662f\u4e00\u4e2a\u53ef\u559c\u7684\u53d8\u5316\u3002<\/span><\/p>\n<blockquote style=\"padding: 8px 12px;border-left-width: 4px;border-left-color: rgb(85, 142, 213);quotes: none;font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;color: rgb(85, 142, 213);height: auto;text-align: left;\"><p><span style=\"font-size: 16px;\"><strong>\u836f\u54c1\u79d1\u5b66\u548c\u4e34\u5e8a\u836f\u7406\u5b66\u54a8\u8be2\u59d4\u5458\u4f1a\u4f1a\u8bae\u4f1a\u524d\u6750\u6599\u4e2d\u5173\u4e8e KASA \u7684\u5185\u5bb9\u7ffb\u8bd1\u5982\u4e0b\uff1a<\/strong><\/span><\/p><\/blockquote>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\"><strong>\u4e3b\u98981\uff1aKASA<\/strong><br  \/><strong>\u77e5\u8bc6\u8f85\u52a9\u8bc4\u4f30\u548c\u7ed3\u6784\u5316\u7533\u8bf7\uff08KASA\uff09\uff1a\u4e00\u79cd\u4f7fFDA\u5bf9\u76d1\u7ba1\u836f\u54c1\u7533\u8bf7\u8d28\u91cf\u8bc4\u4f30\u73b0\u4ee3\u5316\u7684\u65b0\u65b9\u6cd5<\/strong><\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\"><strong>\u4e00\u3001\u7b80\u4ecb<\/strong><\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u53ca\u65f6\u7814\u53d1\u3001\u8bc4\u4f30\u548c\u6279\u51c6\u5b89\u5168\u6709\u6548\u7684\u836f\u54c1\u5bf9\u4e8e\u786e\u4fdd\u7f8e\u56fd\u516c\u4f17\u83b7\u5f97\u4f18\u8d28\u836f\u54c1\u81f3\u5173\u91cd\u8981\u3002\u836f\u54c1\u8d28\u91cf\u529e\u516c\u5ba4\uff08OPQ\uff09\u4e13\u6ce8\u4e8e\u836f\u54c1\u8d28\u91cf\uff0c\u8fd9\u662f\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u65e2\u5b9a\u53c2\u6570\u7684\u57fa\u7840\u3002OPQ\u8d1f\u8d23\u51e0\u4e4e\u6240\u6709\u7c7b\u578b\u7684\u4eba\u7528\u836f\u4e0a\u5e02\u7533\u8bf7\u7684\u8d28\u91cf\u8bc4\u4f30\uff0c\u5305\u62ec\u65b0\u836f\u7533\u8bf7\uff08NDA\uff09\uff0c\u7b80\u5316\u65b0\u836f\u7533\u8bf7\uff08ANDA\uff09\u548c\u751f\u7269\u5236\u54c1\u8bb8\u53ef\u7533\u8bf7\uff08BLA\uff09\uff0c\u5305\u62ec351\uff08k\uff09\u7533\u8bf7\uff08\u5373\u751f\u7269\u7c7b\u4f3c\u836f\uff09\u3002OPQ\u8fd8\u5bf9\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u7533\u8bf7\uff08IND\uff09\u8fdb\u884c\u8d28\u91cf\u8bc4\u4f30\uff0c\u5e76\u4e3a\u975e\u5904\u65b9\u836f\u4ea7\u54c1\u548c\u8bbe\u65bd\u5236\u5b9a\u8d28\u91cf\u6807\u51c6\u3002 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16px;\">\u5efa\u7acb\u98ce\u9669\u8bc6\u522b\u3001\u964d\u4f4e\u548c\u6c9f\u901a\u7b97\u6cd5\uff1b<\/span><\/p>\n<\/li>\n<li>\n<p style=\"text-align: left;\"><span style=\"font-size: 16px;\">\u5bf9\u7533\u8bf7\u8fdb\u884c\u8ba1\u7b97\u673a\u8f85\u52a9\u5206\u6790\uff0c\u6bd4\u8f83\u5df2\u6279\u51c6\u7533\u8bf7\u53ca\u8bbe\u65bd\u7684\u76d1\u7ba1\u6807\u51c6\u548c\u8d28\u91cf\u98ce\u9669;\u4ee5\u53ca<\/span><\/p>\n<\/li>\n<li>\n<p style=\"text-align: left;\"><span style=\"font-size: 16px;\">\u63d0\u4f9b\u7ed3\u6784\u5316\u8bc4\u4f30\uff0c\u5f7b\u5e95\u6d88\u9664\u57fa\u4e8e\u6587\u672c\u7684\u53d9\u8ff0\u548c\u6240\u63d0\u4f9b\u4fe1\u606f\u7684\u6458\u8981<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">KASA\u7cfb\u7edf\u5c06\u4f7f\u7528\u7ed3\u6784\u5316\u6570\u636e\u548c\u4fe1\u606f\u4fc3\u8fdb\u57fa\u4e8e\u95ee\u9898\u7684\u8d28\u91cf\u8bc4\u4f30\uff0c\u4ee5\u63d0\u9ad8\u76d1\u7ba1\u884c\u52a8\u7684\u6548\u7387\u3001\u4e00\u81f4\u6027\u548c\u5ba2\u89c2\u6027\u3002\u672c\u6b21\u54a8\u8be2\u59d4\u5458\u4f1a\u4f1a\u8bae\u5c06\u4ecb\u7ecd\u4fc3\u6210KASA\u7cfb\u7edf\u53d1\u5c55\u7684\u56e0\u7d20\uff0cKASA\u7684\u613f\u666f\u4ee5\u53ca\u5b9e\u65bd\u540e\u53ef\u80fd\u5e26\u6765\u7684\u597d\u5904\u3002 \u4f1a\u8bae\u5c06\u5c31\u76d1\u7ba1\u7533\u8bf7\u7684\u683c\u5f0f\u548c\u5185\u5bb9\u5bfb\u6c42\u610f\u89c1\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><br  \/><span style=\"font-size: 16px;\"><strong>\u4e8c\u3001\u73b0\u72b6\u4ee5\u53ca\u4e3a\u4ec0\u4e48\u9700\u8981KASA<\/strong><\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">FDA\u8ba4\u8bc6\u5230\u5185\u90e8\u53d8\u9769\u7684\u5fc5\u8981\u6027\uff0c\u4ee5\u5e94\u5bf9\u5236\u836f\u5de5\u4e1a\u3001\u516c\u4f17\u9700\u6c42\u548c\u6280\u672f\u8fdb\u6b65\u4e0d\u65ad\u589e\u957f\u7684\u671f\u671b\uff0c\u8ddf\u4e0a21\u4e16\u7eaa\u7684\u6b65\u4f10\u3002\u968f\u7740\u5904\u65b9\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u6cd5\u6848\uff08PDUFA VI\uff09\uff0c\u751f\u7269\u7c7b\u4f3c\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u4fee\u6b63\u6848\uff08BsUFA II\uff09\u548c\u4eff\u5236\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u4fee\u6b63\u6848\uff08GDUFA 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16px;\">\u76ee\u524d\uff0c\u4e66\u9762\u8bc4\u4f30\u7531\u975e\u7ed3\u6784\u5316\u6587\u672c\u7ec4\u6210\uff0c\u5e76\u4e14\u901a\u5e38\u5177\u6709\u8fc7\u591a\u7684\u7533\u8bf7\u6570\u636e\u6458\u8981\uff0c\u5305\u62ec\u6765\u81ea\u5b9e\u9645\u7533\u8bf7\u7684\u201c\u590d\u5236\u548c\u7c98\u8d34\u201d\u7684\u8868\u683c\u548c\u5176\u5b83\u4fe1\u606f\u3002\u56e0\u6b64\uff0c\u5728\u8fd9\u4e9b\u5197\u957f\u7684\u6587\u4ef6\u4e2d\uff0c\u8d28\u91cf\u8bc4\u4f30\u7684\u5173\u952e\u8981\u7d20\uff0c\u5982\u98ce\u9669\u8bc4\u4f30\u548c\u964d\u4f4e\u98ce\u9669\u7684\u65b9\u6cd5\u8bc4\u4f30\uff0c\u5f80\u5f80\u4e0d\u6613\u8bc6\u522b\u3002\u8fd9\u5bfc\u81f4\u7e41\u7410\u7684\u77e5\u8bc6\u7ba1\u7406\u548c\u4f4e\u6548\u7684\u901a\u4fe1\u3002\u6b64\u5916\uff0c\u8bc4\u4f30\u5f88\u5927\u7a0b\u5ea6\u4e0a\u4f9d\u8d56\u4e8e\u8bc4\u4f30\u5458\u7684\u77e5\u8bc6\u548c\u4e13\u4e1a\u6280\u80fd\uff0c\u8fd9\u53ef\u80fd\u4f1a\u5bfc\u81f4\u8bc4\u4f30\u4e0d\u4e00\u81f4\u3002\u867d\u7136OPQ\u9ad8\u5ea6\u91cd\u89c6\u8bc4\u4f30\u5458\u7684\u4e13\u4e1a\u6280\u80fd\uff0c\u4f46\u76ee\u524d\u7684\u65b9\u6cd5\u53d7\u5236\u4e8e\u7f3a\u4e4f\u6570\u636e\u5e93\u4ee5\u83b7\u53d6\u5f53\u524d\u77e5\u8bc6\uff0c\u8fd9\u4e9b\u77e5\u8bc6\u5c06\u6709\u52a9\u4e8e\u83b7\u53d6\u5173\u952e\u4fe1\u606f\u5e76\u505a\u51fa\u66f4\u5ba2\u89c2\u7684\u51b3\u7b56\u3002\u52a0\u4e0a\u77e5\u8bc6\u7ba1\u7406\u5de5\u5177\u4e0d\u8db3\uff0c\u8fd9\u79cd\u975e\u7ed3\u6784\u5316\u6587\u672c\u65b9\u6cd5\u5728\u6bd4\u8f83\u4ea7\u54c1\u65f6\u4f1a\u5bfc\u81f4\u4e0d\u4e00\u81f4\u548c\u56f0\u96be\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u5197\u957f\u7684\u975e\u7ed3\u6784\u5316\u6587\u672c\u53d9\u8ff0\u3001\u5206\u6563\u7684\u4fe1\u606f\u4ee5\u53ca\u7f3a\u4e4f\u6709\u6548\u7684\u77e5\u8bc6\u7ba1\u7406\u4f7f\u5f97OPQ\u96be\u4ee5\u6bd4\u8f83\u836f\u54c1\u548c\u8bbe\u65bd\u7684\u76f8\u5bf9\u8d28\u91cf\u548c\u76f8\u5bf9\u98ce\u9669\u3002\u8fd9\u4f7f\u5f97\u96be\u4ee5\u5728\u4efb\u4f55\u7ed9\u5b9a\u65f6\u95f4\u83b7\u53d6\u4ea7\u54c1\u7684\u201c\u8d28\u91cf\u72b6\u6001\u201d\u3002\u8fd9\u4e00\u70b9\u5728\u8bc4\u4f30\u836f\u54c1\u751f\u547d\u5468\u671f\u4e2d\u4e0a\u5e02\u540e\u8d28\u91cf\u53d8\u66f4\u7684\u5269\u4f59\u98ce\u9669\u65f6\u5c24\u4e3a\u660e\u663e\u3002\u8fd9\u4e9b\u6311\u6218\u53ef\u80fd\u5bfc\u81f4\u5728\u9884\u9632\u6216\u89e3\u51b3\u836f\u54c1\u77ed\u7f3a\u6216\u5df2\u4e0a\u5e02\u836f\u54c1\u8d28\u91cf\u5931\u6548\u65b9\u9762\u7684\u540e\u671f\u5e72\u9884\u3002\u4e3a\u4e86\u5e94\u5bf9\u4e0a\u8ff0\u6311\u6218\uff0cOPQ\u6b63\u5728\u5f00\u53d1KASA\u7cfb\u7edf\uff0c\u4ee5\u4f7f\u836f\u54c1\u7533\u8bf7\u7684\u8d28\u91cf\u8bc4\u4f30\u73b0\u4ee3\u5316\uff0c\u5305\u62ec\u7ed3\u6784\u5316\u7684\u4fe1\u606f\u3002\u8fd9\u4fc3\u8fdb\u4e86\u4e00\u81f4\u6027\uff0c\u5e76\u63d0\u4f9b\u4e86\u4e00\u4e2a\u6025\u9700\u7684\u77e5\u8bc6\u7ba1\u7406\u5de5\u5177\uff0c\u53ef\u4ee5\u63d0\u9ad8\u6548\u7387\u548c\u6574\u4f53\u8d28\u91cf\u8bc4\u4f30\u6d41\u7a0b\u3002<\/span><\/p>\n<p 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style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><br  \/><span style=\"font-size: 16px;\"><strong>\u4e94\u3001\u7ed3\u8bba<\/strong><\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">KASA\u662f\u4e00\u4e2a\u65e8\u5728\u4f7f\u76d1\u7ba1\u836f\u54c1\u7533\u8bf7\u7684\u8d28\u91cf\u8bc4\u4f30\u73b0\u4ee3\u5316\u7684\u65b0\u7cfb\u7edf\u3002KASA\u4ee3\u8868\u4e86\u4ece\u8fc7\u53bb\u8fc7\u65f6\u7684\u8bc4\u4f30\u5b9e\u8df5\u5230\u65b0\u7684\u3001\u66f4\u6709\u6548\u7684\u4fe1\u606f\u548c\u8d44\u6e90\u5904\u7406\u65b9\u5f0f\u7684\u6982\u5ff5\u8f6c\u53d8\u3002\u5b8c\u5168\u5f00\u53d1\u548c\u5b9e\u65bd\u540e , KASA\u5c06\u6709\u52a9\u4e8e\uff1a<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">1.\u901a\u8fc7\u77e5\u8bc6\u7ba1\u7406\u786e\u4fdd\u60a3\u8005\u5173\u6ce8\u7684\u8d28\u91cf\u6807\u51c6\u548c\u76d1\u7ba1\u884c\u52a8\u7684\u5ba2\u89c2\u6027\uff1b<br  \/>2.\u901a\u8fc7\u65e2\u5b9a\u7b97\u6cd5\u52a0\u5f3a\u57fa\u4e8e\u79d1\u5b66\u548c\u98ce\u9669\u7684\u76d1\u7ba1\u65b9\u6cd5\uff1b\u4ee5\u53ca<br  \/>3.\u901a\u8fc7\u4ea7\u54c1\u548c\u8bbe\u65bd\u7684\u751f\u547d\u5468\u671f\u7ba1\u7406\u5f3a\u5316\u76d1\u7ba1\u76d1\u7763<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u6700\u7ec8\uff0cKASA\u7cfb\u7edf\u63a8\u52a8\u4e86OPQ\u5bf9\u836f\u54c1\u8d28\u91cf\u7684\u5173\u6ce8 , \u8fd9\u662f\u786e\u4fdd\u836f\u54c1\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u57fa\u7840\u3002\u5b83\u901a\u8fc7\u73b0\u4ee3\u5316\u5c06FDA\u7684\u8d28\u91cf\u76d1\u7763\u63d0\u5347\u5230\u4e86\u4e00\u4e2a\u65b0\u7684\u6c34\u5e73\u3002<\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><br  \/><span style=\"font-size: 16px;\"><strong>\u59d4\u5458\u4f1a\u8ba8\u8bba\u8981\u70b9\u8349\u6848<\/strong><\/span><\/p>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u5173\u4e8eKASA\u5021\u8bae\uff0cFDA\u662f\u5426\u5e94\u8003\u8651\u589e\u52a0\u63d0\u4ea4\u683c\u5f0f\u4ee5\u63d0\u9ad8\u76d1\u7ba1\u8d28\u91cf\u8bc4\u4f30\u7684\u6548\u7387\u548c\u4e00\u81f4\u6027\uff1f<\/span><\/p>\n<blockquote>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;color: rgb(85, 142, 213);\"><strong>\u76f8\u5173\u9605\u8bfb\uff1a<\/strong><br  \/><\/span><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzA5MDAyNjQxMw==&amp;mid=2650389953&amp;idx=1&amp;sn=f87fd2e4af3d1497f72bbd9d547892a8&amp;chksm=881ce503bf6b6c151f55a46e036c09684913ed0493e90ed552ddba14fc21c0dd264ebc1802d8&amp;scene=21#wechat_redirect\" target=\"_blank\"><span style=\"text-decoration: underline;font-size: 16px;\">\u3010FDA \u5c40\u957f\u8c08\u4eff\u5236\u836f\u5ba1\u8bc4\u4e0e\u77e5\u8bc6\u7ba1\u7406 2018\/06\/20\u3011<\/span><\/a><br  \/><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzA5MDAyNjQxMw==&amp;mid=2650389417&amp;idx=1&amp;sn=08b8a4af750548ab479cdb77668a5e94&amp;chksm=881ce36bbf6b6a7d1563db4ef7c082e4ea506f31245e51d1c2ca1d74531e95645dcf050be716&amp;scene=21#wechat_redirect\" target=\"_blank\" style=\"text-decoration: underline;\"><span style=\"font-size: 16px;\">\u3010FDA \u836f\u54c1\u4e2d\u5fc3\u4e3b\u4efb\u8bc4\u8bae\u4eff\u5236\u836f\u8bc4\u4f30\u65b0\u8303\u5f0f 2018\/02\/15\u3011<\/span><\/a><\/p>\n<\/blockquote>\n<p style=\"margin-bottom: 0.5em;line-height: 22px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;\"><span style=\"font-size: 16px;\">\u7f16\u8bd1\uff1a\u8bc6\u6797-\u96ea\u6749\u3001\u8bc6\u6797-\u6912<\/p>\n<p><\/span><\/p>\n<blockquote>\n<p style=\"margin-bottom: 0.5em;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;white-space: normal;text-align: left;line-height: normal;\"><span style=\"font-size: 13px;\"><strong>\u53c2\u8003\u8d44\u6599<\/strong><\/span><\/p>\n<p style=\"text-align: left;line-height: normal;\"><span style=\"font-size: 13px;\">Me KASA es Su KASA \u2013 Long Overdue but Very Welcome &#8211; Lachman Consultants<\/span><\/p>\n<\/blockquote>\n<p style=\"white-space: normal;\"><img width=\"100%\"          class=\"\" style=\"max-width: 558px;color: rgb(85, 85, 85);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;font-size: 13px;letter-spacing: 0.54px;width: 558px;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/3-1538274121.png\" alt=\"FDA \u77e5\u8bc6\u8f85\u52a9\u8bc4\u4f30\u548c\u7ed3\u6784\u5316\u7533\u8bf7\u8ba1\u5212\u63d0\u4e0a\u8bae\u7a0b\" title=\"FDA \u77e5\u8bc6\u8f85\u52a9\u8bc4\u4f30\u548c\u7ed3\u6784\u5316\u7533\u8bf7\u8ba1\u5212\u63d0\u4e0a\u8bae\u7a0b\"  \/><br  \/><\/p>\n<p style=\"white-space: normal;\"><a href=\"http:\/\/mp.weixin.qq.com\/s?__biz=MzA5MDAyNjQxMw==&amp;mid=2650389899&amp;idx=1&amp;sn=f62949c3b8c99e5083619c654d1bed14&amp;chksm=881ce549bf6b6c5f408b0a4af665781efae988472b7ed61fc6d105b6dff6960be5f62efc4c57&amp;scene=21#wechat_redirect\" target=\"_blank\" style=\"color: rgb(87, 107, 149);text-decoration: underline;-webkit-tap-highlight-color: rgba(0, 0, 0, 0);font-size: 16px;\"><span style=\"color: rgb(62, 62, 62);font-family: \u5fae\u8f6f\u96c5\u9ed1, sans-serif;widows: 1;\"><strong><span style=\"color: rgb(85, 142, 213);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;\">\u3010\u5173\u4e8e\u8bc6\u6797 &#8211; \u5e38\u89c1\u95ee\u9898\u4e0e\u89e3\u7b54<\/span><\/strong><\/span><span style=\"color: rgb(61, 170, 214);font-family: \u5fae\u8f6f\u96c5\u9ed1, sans-serif;widows: 1;\"><strong><span style=\"color: rgb(85, 142, 213);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;\">\u3011<\/span><\/strong><\/span><\/a><br  \/><\/p>\n<p style=\"white-space: normal;\"><img width=\"100%\"          class=\"\" style=\"max-width: 558px;width: 558px;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/6-1538274121.png\" alt=\"FDA \u77e5\u8bc6\u8f85\u52a9\u8bc4\u4f30\u548c\u7ed3\u6784\u5316\u7533\u8bf7\u8ba1\u5212\u63d0\u4e0a\u8bae\u7a0b\" title=\"FDA \u77e5\u8bc6\u8f85\u52a9\u8bc4\u4f30\u548c\u7ed3\u6784\u5316\u7533\u8bf7\u8ba1\u5212\u63d0\u4e0a\u8bae\u7a0b\"  \/><\/p>\n<p style=\"white-space: normal;text-align: center;\"><span style=\"font-size: 16px;\"><strong><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;\">\u957f\u6309\u4e0b\u65b9\u4e8c\u7ef4\u7801\u4e0b\u8f7d<\/span><\/strong><strong><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;\"><span style=\"letter-spacing: 0.54px;line-height: 22px;text-indent: 26px;widows: 1;\">\u8bc6\u6797<\/span><sup style=\"color: rgb(85, 85, 85);font-size: 10px;letter-spacing: 0.54px;line-height: 22px;text-indent: 26px;widows: 1;\">\u00ae<\/sup><\/span><\/strong><strong><span style=\"font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;\"><span style=\"letter-spacing: 0.54px;text-indent: 26px;widows: 1;\"><\/span>App<\/span><\/strong><\/span><\/p>\n<p style=\"white-space: normal;\">\n<p style=\"font-size: 16px;white-space: normal;font-variant-numeric: normal;text-align: center;\"><strong style=\"color: rgb(62, 62, 62);font-family: \u5fae\u8f6f\u96c5\u9ed1, \u5b8b\u4f53, Arial, Helvetica;letter-spacing: 0.54px;line-height: 28px;text-align: justify;text-indent: 30px;widows: 1;\"><span style=\"color: rgb(0, 0, 0);\"><span style=\"color: rgb(192, 0, 0);letter-spacing: 0.54px;text-align: center;text-indent: 28px;\">\u8bc6\u6797<\/span><sup style=\"color: rgb(192, 0, 0);font-size: 10px;letter-spacing: 0.54px;text-align: center;text-indent: 16.66px;\"><span style=\"font-size: 16px;line-height: 22px;\">\u00ae<\/span><\/sup><span style=\"color: rgb(192, 0, 0);letter-spacing: 0.54px;text-align: center;text-indent: 28px;\">\u7248\u6743\u6240\u6709\uff0c\u672a\u7ecf\u8bb8\u53ef\u4e0d\u5f97\u8f6c\u8f7d\u3002<\/span><\/span><\/strong><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd FDA \u4e8e 9 \u6708 20 \u65e5\u53ec\u5f00\u836f\u54c1\u79d1\u5b66\u548c\u4e34\u5e8a\u836f\u7406\u5b66\u54a8\u8be2\u59d4\u5458\u4f1a\u4f1a\u8bae\uff0c\u8ba8\u8bba FDA \u77e5\u8bc6\u8f85\u52a9\u8bc4\u4f30\u548c\u7ed3\u6784\u5316\u7533 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":57016,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57015"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=57015"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57015\/revisions"}],"predecessor-version":[{"id":57021,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57015\/revisions\/57021"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/57016"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=57015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=57015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=57015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}