3\u670816\u65e5\u6d88\u606f\uff0c\u636e\u5916\u7535\u62a5\u9053\uff0c\u7f8e\u56fd\u603b\u7edf\u62dc\u767b\u5468\u4e8c\u7b7e\u7f72\u4e86\u4e00\u9879\u6cd5\u6848\uff0c\u8d4b\u4e88\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\u5bf9\u4efb\u4f55\u5c3c\u53e4\u4e01\u7684\u6743\u529b\uff0c\u800c\u4e0d\u4ec5\u4ec5\u662f\u70df\u8349\u884d\u751f\u7684\u5c3c\u53e4\u4e01\u3002\u4f5c\u4e3a 1.5 \u4e07\u4ebf\u7f8e\u5143\u7684\u653f\u5e9c\u652f\u51fa\u63aa\u65bd\u7684\u4e00\u90e8\u5206\uff0c\u8fd9\u9879\u76d1\u7ba1\u5728\u6ca1\u6709\u8fa9\u8bba\u6216\u901a\u77e5\u7535\u5b50\u70df\u884c\u4e1a\u7684\u60c5\u51b5\u4e0b\u88ab\u7eb3\u5165\u8be5\u6cd5\u6848\u3002<\/p>\n
<\/p>\n
\u300a\u70df\u8349\u63a7\u5236\u6cd5\u300b\u7684\u63aa\u8f9e\u73b0\u5728\u5c06\u6539\u53d8\uff0c\u5c06\u70df\u8349\u4ea7\u54c1\u5b9a\u4e49\u4e3a\u4efb\u4f55\u7531\u70df\u8349\u5236\u6210\u6216\u884d\u751f\u7684\u4ea7\u54c1\uff0c\u6216\u542b\u6709\u6765\u81ea\u4efb\u4f55\u6765\u6e90\u7684\u5c3c\u53e4\u4e01\uff0c\u4f9b\u4eba\u7c7b\u6d88\u8d39\u7684\u4ea7\u54c1\u3002<\/p>\n
\u62dc\u767b\u8bf4\uff1a\u300c\u4f60\u77e5\u9053\uff0c\u9a6c\u4e0a\uff0c\u6211\u5c06\u7b7e\u7f72\u8fd9\u9879\u4e24\u515a\u653f\u5e9c\u8d44\u52a9\u6cd5\u6848\u3002\u4f46\u901a\u8fc7\u8fd9\u9879\u6cd5\u6848\uff0c\u6211\u4eec\u5c06\u5411\u7f8e\u56fd\u4eba\u6c11\u4f20\u8fbe\u4e00\u4e2a\u4fe1\u606f\u2014\u2014\u4e00\u4e2a\u5f3a\u70c8\u7684\u4fe1\u606f\u2014\u2014\u6c11\u4e3b\u515a\u4eba\u548c\u5171\u548c\u515a\u4eba\u5b9e\u9645\u4e0a\u53ef\u4ee5\u8d70\u5230\u4e00\u8d77\uff0c\u5b8c\u6210\u4e00\u4e9b\u4e8b\u60c5\u3002\u300d<\/p>\n
Troutman Pepper \u7684\u5408\u4f19\u4eba Bryan Haynes \u8868\u793a\uff0c\u8be5\u4fee\u6b63\u6848\u5728\u6cd5\u6848\u9881\u5e03\u540e 30 \u5929\u751f\u6548\uff0c\u5e76\u5728\u6cd5\u6848\u9881\u5e03\u540e 30 \u5929\u7ed9\u4e88\u542b\u6709\u5408\u6210\u5c3c\u53e4\u4e01\uff08\u6216\u975e\u70df\u8349\u6765\u6e90\u7684\u5c3c\u53e4\u4e01\uff09\u7684\u70df\u8349\u4ea7\u54c1\u5236\u9020\u5546\u3002<\/p>\n
\u300c\u5982\u679c FDA \u5728\u751f\u6548\u65e5\u671f\u540e 90 \u5929\u5185\u672a\u6279\u51c6\u8be5\u4ea7\u54c1\uff0c\u5219\u8be5\u4ea7\u54c1\u5fc5\u987b\u4ece\u5e02\u573a\u4e0a\u64a4\u51fa\u3002\u8fd9\u53ef\u80fd\u76f8\u5f53\u4e8e\u5bf9\u5408\u6210\u5c3c\u53e4\u4e01\u4ea7\u54c1\u7684\u6709\u6548\u7981\u4ee4\u3002\u300d\u4ed6\u5199\u9053\u3002\u300c\u5f53\u5176\u4ed6\u7528\u4e8e\u7535\u5b50\u5c3c\u53e4\u4e01\u8f93\u9001\u7cfb\u7edf\u7684 PMTA \u5df2\u7ecf\u60ac\u800c\u672a\u51b3\u4e24\u5e74\u591a\u65f6\uff0cFDA \u6781\u4e0d\u53ef\u80fd\u5728 90 \u5929\u5185\u6279\u51c6 PMTA\u3002\u300d<\/p>\n
\u65e0\u70df\u66ff\u4ee3\u54c1\u8d38\u6613\u534f\u4f1a (SFATA) \u8463\u4e8b\u4f1a\u4e3b\u5e2d April Meyers\u8868\u793a\uff0c\u8be5\u6cd5\u6848\u5bf9\u9752\u5c11\u5e74\u5438\u7535\u5b50\u70df\u5f71\u54cd\u4e0d\u5927\uff0c\u81ea 2015 \u5e74\u7684\u9ad8\u70b9\u4ee5\u6765\u5df2\u7ecf\u5927\u5e45\u4e0b\u964d\uff0c\u662f\u4e3a\u4e86\u5835\u4f4f\u73b0\u5728\u5728\u5e74\u8f7b\u4eba\u4e2d\u6d41\u884c\u7684\u5927\u516c\u53f8\u7684\u5408\u6210\u5c3c\u53e4\u4e01\u884d\u751f\u4ea7\u54c1\u7684\u6f0f\u6d1e\uff0c\u73b0\u5b9e\u60c5\u51b5\u662f\uff0c\u8fd9\u9879\u6cd5\u6848\u2014\u2014\u4ee5\u53ca\u5176\u4ed6\u7c7b\u4f3c\u7684\u6cd5\u6848\u2014\u2014\u4e0d\u592a\u53ef\u80fd\u4ea7\u751f\u9884\u671f\u7684\u6548\u679c\u3002<\/p>\n
\u5979\u8bf4\uff0c\u76f8\u53cd\uff0c\u4f7f\u7528\u8fd9\u4e9b\u4ea7\u54c1\u4f5c\u4e3a\u51cf\u5c11\u5371\u5bb3\u9009\u62e9\u7684\u6d88\u8d39\u8005\u5c06\u53d7\u5230\u5f71\u54cd\uff0c\u5b8c\u5168\u9075\u5b88\u8054\u90a6\u3001\u5dde\u548c\u5730\u65b9\u6cd5\u5f8b\u7684\u6301\u724c\u5c0f\u4f01\u4e1a\u4e5f\u4f1a\u53d7\u5230\u5f71\u54cd\u3002<\/p>\n
\u300cFDA \u8fc7\u5ea6\u76d1\u7ba1\u4e86\u6570\u767e\u4e07\u6210\u5e74\u4eba\u4f7f\u7528\u7684\u4ea7\u54c1\uff0c\u8fd9\u4e9b\u6210\u5e74\u4eba\u53d1\u73b0\u7535\u5b50\u70df\u662f\u4e00\u79cd\u66f4\u5b89\u5168\u7684\u5438\u70df\u66ff\u4ee3\u54c1\u3002\u5f53\u9700\u6c42\u91cf\u5927\u7684\u5e02\u573a\u53d7\u5230\u8fc7\u5ea6\u76d1\u7ba1\u65f6\uff0c\u7070\u8272\u548c\u9ed1\u8272\u5e02\u573a\u5c31\u4f1a\u51fa\u73b0\uff0c\u800c\u8fd9\u4e9b\u5e02\u573a\u6ca1\u6709\u8981\u6c42\u5b89\u5168\u4ea7\u54c1\u6216\u8eab\u4efd\u68c0\u67e5\u7684\u89c4\u5b9a\u3002\u300d<\/p>\n
\u4ee5\u4e0b\u622a\u6b62\u65e5\u671f\u73b0\u5728\u9002\u7528\u4e8e\u4efb\u4f55\u542b\u6709\u6765\u81ea\u4efb\u4f55\u6765\u6e90\u7684\u5c3c\u53e4\u4e01\uff08\u5305\u62ec\u5408\u6210\u5c3c\u53e4\u4e01\uff09\u7684\u70df\u8349\u4ea7\u54c1\uff1a<\/p>\n
\u9881\u5e03\u65e5\u671f\uff1a 2022 \u5e74 3 \u6708 11 \u65e5\uff08\u62dc\u767b\u603b\u7edf\u7b7e\u7f72\u6cd5\u6848\u7684\u65e5\u671f\uff09<\/p>\n
\u751f\u6548\u65e5\u671f\uff1a 2022 \u5e74 4 \u6708 11 \u65e5\uff08\u9881\u5e03\u65e5\u671f\u540e 30 \u5929\uff09<\/p>\n
PMTA \u63d0\u4ea4\u622a\u6b62\u65e5\u671f\uff1a 2022 \u5e74 5 \u6708 11 \u65e5\uff08\u5236\u9020\u5546\u5fc5\u987b\u5411 FDA \u63d0\u4ea4\u542b\u6709\u6765\u81ea\u4efb\u4f55\u6765\u6e90\u7684\u5c3c\u53e4\u4e01\uff08\u5305\u62ec\u5408\u6210\u5c3c\u53e4\u4e01\uff09\u7684\u70df\u8349\u4ea7\u54c1\u7684\u4e0a\u5e02\u524d\u70df\u8349\u7533\u8bf7\u4ee5\u4fdd\u6301\u4ea7\u54c1\u4e0a\u5e02\u7684\u65e5\u671f\u800c FDA \u5ba1\u67e5 PMTA\uff09<\/p>\n
FDA \u547d\u4ee4\u622a\u6b62\u65e5\u671f\uff1a 2022 \u5e74 7 \u6708 11 \u65e5\uff08FDA \u5fc5\u987b\u53d1\u5e03\u8425\u9500\u6388\u6743\u547d\u4ee4\u4ee5\u54cd\u5e94\u63d0\u4ea4\u7684 PMTA \u4ee5\u5141\u8bb8\u542b\u6709\u5408\u6210\u5c3c\u53e4\u4e01\u7684\u70df\u8349\u4ea7\u54c1\u5728 2022 \u5e74 7 \u6708 11 \u65e5\u4e4b\u540e\u7ee7\u7eed\u5728\u5e02\u573a\u4e0a\u9500\u552e\u7684\u65e5\u671f\uff09<\/p>\n
<\/p>\n
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