{"id":7506,"date":"2024-08-31T13:09:02","date_gmt":"2024-08-31T05:09:02","guid":{"rendered":"https:\/\/regask.com\/?p=7506"},"modified":"2024-09-25T02:19:23","modified_gmt":"2024-09-24T18:19:23","slug":"fda-2024-%e4%bb%bf%e5%88%b6%e8%8d%af%e7%a0%94%e8%ae%a8%e4%bc%9a","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-2024-generic-drug-workshop\/","title":{"rendered":"\u7f8e\u56fdFDA 2024\u5e74\u63a8\u8fdb\u4eff\u5236\u836f\u53d1\u5c55\u2026"},"content":{"rendered":"<p>FDA \u836f\u54c1\u8bc4\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3 (CDER) \u5c0f\u578b\u4f01\u4e1a\u548c\u884c\u4e1a\u63f4\u52a9 (SBIA) \u5c06\u4e8e 2024 \u5e74 9 \u6708 24 \u65e5\u81f3 25 \u65e5\u4e3e\u529e\u5907\u53d7\u671f\u5f85\u7684 2024 \u5e74\u63a8\u8fdb\u4eff\u5236\u836f\u5f00\u53d1\u7814\u8ba8\u4f1a\u3002<\/p>\n<p>\u672c\u6b21\u7814\u8ba8\u4f1a\u662f\u4eff\u5236\u836f\u884c\u4e1a\u4e13\u4e1a\u4eba\u58eb\u4e86\u89e3\u6700\u65b0\u79d1\u5b66\u548c\u76d1\u7ba1\u8fdb\u5c55\u7684\u91cd\u8981\u673a\u4f1a\u3002\u65e0\u8bba\u662f\u4eb2\u4e34\u73b0\u573a\u8fd8\u662f\u901a\u8fc7\u865a\u62df\u65b9\u5f0f\u53c2\u52a0\uff0c\u53c2\u4e0e\u8005\u90fd\u5c06\u83b7\u5f97\u5207\u5b9e\u53ef\u884c\u7684\u89c1\u89e3\uff0c\u5e76\u66f4\u597d\u5730\u4e86\u89e3\u4eff\u5236\u836f\u5f00\u53d1\u7684\u672a\u6765\u524d\u666f\u3002<\/p>\n<p><strong>\u7814\u8ba8\u4f1a\u91cd\u70b9\u9886\u57df<\/strong><\/p>\n<p>\u7814\u8ba8\u4f1a\u5c06\u6df1\u5165\u63a2\u8ba8\u63a8\u52a8\u4eff\u5236\u836f\u884c\u4e1a\u53d1\u5c55\u7684\u5173\u952e\u8bae\u9898\uff0c\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u4f53\u5916\u8868\u5f81\u8fdb\u5c55<\/strong>\uff1a\u63a2\u7d22\u589e\u5f3a\u4eff\u5236\u836f\u4f53\u5916\u8868\u5f81\u7684\u6700\u65b0\u65b9\u6cd5\u3002<\/li>\n<li><strong>\u6307\u5bfc\u53d1\u5c55\u7814\u7a76<\/strong>\uff1a\u4e86\u89e3 FDA \u65e8\u5728\u4e3a\u590d\u6742\u4ea7\u54c1\u5236\u5b9a\u6307\u5bfc\u7684\u7814\u7a76\u4e3e\u63aa\u3002<\/li>\n<li><strong>\u786e\u4fdd\u8d28\u91cf\u548c\u6548\u7387<\/strong>\uff1a\u4e86\u89e3\u4e3a\u786e\u4fdd\u4eff\u5236\u836f\u9ad8\u6548\u5f00\u53d1\u548c\u9ad8\u8d28\u91cf\u800c\u6b63\u5728\u8fdb\u884c\u7684\u52aa\u529b\u3002<\/li>\n<\/ul>\n<p>\u53c2\u4e0e\u8005\u8fd8\u5c06\u6df1\u5165\u4e86\u89e3 FDA \u4eff\u5236\u836f\u7528\u6237\u8d39\u7528\u4fee\u6b63\u6848 (GDUFA) \u79d1\u5b66\u4e0e\u7814\u7a76\u8ba1\u5212\u5bf9\u4eff\u5236\u836f\u5f00\u53d1\u3001\u76d1\u7ba1\u548c\u6279\u51c6\u7684\u5f71\u54cd\u3002<\/p>\n<p><strong>\u7814\u8ba8\u4f1a\u65e5\u7a0b<\/strong><\/p>\n<ul>\n<li><strong>\u7b2c 1 \u5929<\/strong>\uff1a 2024 \u5e74 9 \u6708 24 \u65e5\u4e0a\u5348 8:30 \u2013 \u4e0b\u5348 4:35\uff08\u7f8e\u56fd\u4e1c\u90e8\u65f6\u95f4\uff09<\/li>\n<li><strong>\u7b2c 2 \u5929<\/strong>\uff1a 2024 \u5e74 9 \u6708 25 \u65e5\u4e0a\u5348 9:00 \u2013 \u4e0b\u5348 4:15\uff08\u7f8e\u56fd\u4e1c\u90e8\u65f6\u95f4\uff09<\/li>\n<\/ul>\n<a href=\"https:\/\/regask.com\/zh\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" class=\"button primary is-link is-medium\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u66f4\u591a<\/span>\n\t<\/a>\n\n<p>\u00a9\u672c RegAlert \u7531 RegASK \u53d1\u5e03<\/p>","protected":false},"excerpt":{"rendered":"<p>The FDA&#8217;s Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) is set to host the highly anticipated 2024 Advancing Generic Drug Development Workshop on September 24-25, 2024. 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