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!important;border-right-color: transparent !important;\"><\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px 10px 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;width: 677px;vertical-align: top;letter-spacing: 0px;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px 5px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: justify;font-size: 17px;line-height: 1.7;color: rgb(62, 62, 62);\">\n<p style=\"margin: 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normal;\">\u751f\u4ea7\u5546\u5bf9\u4e8e\u91c7\u53d6\u82e5\u5e72\u4e3e\u63aa\u6765\u89e3\u51b3\u8fd9\u4e00\u56f0\u96be\u548c\u591a\u65b9\u9762\u7684\u95ee\u9898\u6709\u5f88\u9ad8\u7684\u671f\u671b\uff0cFDA\u4e5f\u6025\u4e8e\u53d6\u5f97\u8fdb\u5c55\u3002\u9996\u5148\uff0c\u6211\u4eec\u5e94\u8be5\u4ece\u5236\u836f\u884c\u4e1a\u7684\u89d2\u5ea6\u6765\u770b\u5f85\u8fd9\u4e2a\u95ee\u9898\u3002\u5982\u4f55\u5904\u7406\u6536\u96c6\u5230\u7684\u91cf\u5ea6\u6570\u636e\uff08\u5982\u4f55\u7ba1\u7406\u6570\u636e\uff0c\u5982\u4f55\u4fdd\u6301\u673a\u5bc6\u6027\u7b49\uff09\u4ee5\u53ca\u5982\u4f55\u4f7f\u7528\u6570\u636e\uff08\u5c06\u5176\u6807\u51c6\u5316\uff0c\u662f\u5426\u5c06\u4e0e\u5176\u4ed6\u64cd\u4f5c\u8fdb\u884c\u6bd4\u8f83\uff0c\u662f\u5426\u5c06\u4e0e\u5176\u4ed6\u6570\u636e\u6c47\u603b\u4ee5\u8fdb\u884c\u57fa\u4e8e\u98ce\u9669\u7684\u5168\u9762\u8bc4\u4f30\u7b49\uff09\u662f\u4e3b\u8981\u7684\u5173\u6ce8\u70b9\u3002\u957f\u671f\u4ee5\u6765\uff0c\u5236\u836f\u884c\u4e1a\u7684\u5408\u89c4\u72b6\u51b5\u4e00\u76f4\u7531cGMP\u68c0\u67e5\u6765\u8fdb\u884c\u7ba1\u7406\uff0c\u4e0d\u5408\u89c4\u60c5\u51b5\u53ef\u80fd\u4f1a\u5bfc\u81f4\u6210\u672c\u589e\u52a0\u548c\u8d1f\u9762\u5f71\u54cd\u3002\u76f8\u5bf9\u7684\uff0c\u5236\u836f\u884c\u4e1a\u5e94\u8be5\u4e0d\u65ad\u63d0\u9ad8\u4ea7\u54c1\u8d28\u91cf\uff0c\u4fdd\u969c\u60a3\u8005\u5b89\u5168\u5e94\u662f\u6700\u91cd\u8981\u7684\u76ee\u6807\u3002<\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: normal;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: normal;\">FDA\u81ea2015\u5e747\u6708\u53d1\u5e03\u300a\u8d28\u91cf\u91cf\u5ea6\u8981\u6c42\u6307\u5357\u8349\u6848\u300b\u4ee5\u6765\uff0c\u786e\u5b9e\u52a0\u5f3a\u4e86\u5bf9\u884c\u4e1a\u5efa\u8bae\u7684\u5173\u6ce8\uff0c\u6700\u8fd1\u53d1\u5e03\u7684FRN\u53ef\u4ee5\u8bc1\u660e\u8fd9\u4e00\u70b9\u3002\u56fd\u9645\u5236\u836f\u5de5\u7a0b\u5b66\u4f1a\uff08ISPE\uff09\u4e00\u76f4\u5021\u5bfc\u5b9e\u65bd\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u7684\u5fc5\u8981\u6027\uff0c\u5e76\u81f4\u529b\u4e8e\u63d0\u4f9b\u57fa\u4e8e\u6570\u636e\u7684\u5efa\u8bae\u548c\u5bf9\u4ea4\u53c9\u884c\u4e1a\uff08\u5236\u836f\uff0c\u751f\u7269\u6280\u672f\uff0cOTC\uff0cAPI\u7b49\u7684\u4ea4\u53c9\u884c\u4e1a\uff09\u7684\u8bc4\u8bba\uff0c\u8fd9\u5728\u6700\u8fd1\u53d1\u5e03\u7684FRN\u4e2d\u6709\u6240\u53cd\u6620\u3002\u5177\u4f53\u800c\u8a00\uff0c\u8be5\u6307\u5357\u8981\u6c42 FDA\u4ece\u5c0f\u89c4\u6a21\u5f00\u59cb\u5b9e\u65bd\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\uff0c\u5728\u521d\u671f\u91c7\u53d6\u81ea\u613f\u65b9\u5f0f\uff0c\u4e14\u9700\u4fdd\u6301\u6570\u636e\u7684\u673a\u5bc6\u6027\u3002\u9664\u6700\u8fd1\u53d1\u5e03\u7684\u300a\u8054\u90a6\u516c\u62a5\u300b\u516c\u544a\u6587\u4ef6\uff08FRN\uff09\u8be6\u7ec6\u8bf4\u660eFDA\u5c06\u91c7\u7eb3\u884c\u4e1a\u5efa\u8bae\u5916\uff0cFDA\u8fd8\u53d1\u5e03\u4e86\u7b2c\u4e8c\u4efdFRN\uff08Docket No. FDA-2018-N-1896\uff09\uff0c\u5f3a\u8c03\u5e94\u8fdb\u884c\u73b0\u573a\u8003\u67e5\u4ee5\u4fc3\u8fdbCDER\u548cCBER\u5458\u5de5\u7684\u4f53\u9a8c\u5f0f\u5b66\u4e60\u3002\u8fd9\u4e2a\u673a\u4f1a\u53ef\u4ee5\u4f7f\u884c\u4e1a\u4e0eFDA\u4e00\u8d77\u786e\u5b9a\u201c\u4e0e\u5b9e\u65bd\u548c\u7ba1\u7406\u7a33\u5065\u7684\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u76f8\u5173\u7684FDA\u804c\u5458\u9762\u4e34\u7684\u591a\u4e2a\u4f18\u52bf\u548c\u6311\u6218\u201d\u3002<\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: normal;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: normal;\">\u836f\u54c1\u751f\u4ea7\u64cd\u4f5c\u53ef\u4ee5\u975e\u5e38\u7b80\u5355\uff08\u4ece\u5730\u7406\u4f4d\u7f6e\uff0c\u7ba1\u7406\u548c\u63a7\u5236\u7684\u89d2\u5ea6\u6765\u770b\uff09\uff0c\u4f46\u4e5f\u53ef\u80fd\u975e\u5e38\u590d\u6742\u3002\u4e00\u4e2a\u7b80\u5355\u7684\u751f\u4ea7\u64cd\u4f5c\u53ef\u80fd\u4ec5\u5305\u62ec\u7b80\u5355\u7684\u975e\u590d\u6742\u6027\u7a0b\u5e8f\uff0c\u5305\u62ec\u5185\u90e8\u7269\u6599\u63a5\u6536\u3001\u6d4b\u8bd5\u3001\u751f\u4ea7\u3001\u5305\u88c5\uff0c\u4ee5\u53ca\u5411\u4e0d\u540c\u5206\u9500\u5546\u7684\u914d\u9001\u3002\u590d\u6742\u7684\u751f\u4ea7\u64cd\u4f5c\u53ef\u80fd\u6d89\u53ca\u591a\u4e2a\u6d4b\u8bd5\uff0c\u751f\u4ea7\u548c\u5305\u88c5\u573a\u5730\u95ee\u9898\uff0c\u4ece\u800c\u5e26\u6765\u5927\u89c4\u6a21\u7684\u7269\u6d41\u3001\u4f9b\u5e94\u94fe\u534f\u8c03\u548c\u7ba1\u7406\u96be\u5ea6\u7684\u6311\u6218\uff0c\u6b64\u5916\uff0c\u8fd8\u6d89\u53ca\u5230\u7ade\u4e89\u4f18\u5148\u6743\u95ee\u9898\uff08competing priorities\uff09\u3002\u867d\u7136NDA\u548cANDA\u6301\u6709\u4eba\u5e0c\u671b\u6700\u5927\u9650\u5ea6\u5730\u4e0e\u5176\u4ed6\u5229\u76ca\u76f8\u5173\u65b9\u5206\u5305\u8d23\u4efb\uff0c\u4f46\u516c\u53f8\u5185\u90e8\u7684\u5229\u6da6\u4e2d\u5fc3\u3001\u5916\u5305\u5b9e\u9a8c\u5ba4\u3001\u5408\u540c\u5236\u9020\u5546\u3001\u5408\u540c\u5916\u5305\u5546\u7b49\u90fd\u8bd5\u56fe\u5c06\u81ea\u8eab\u8d23\u4efb\u6700\u5c0f\u5316\u5e76\u83b7\u53d6\u5229\u76ca\uff0c\u800c\u8fd9\u5c06\u5bfc\u81f4\u5404\u65b9\u5229\u76ca\u51b2\u7a81\u95ee\u9898\u3002\u6536\u96c6\u8fd9\u4e9b\u4f9b\u5e94\u94fe\u4e2d\u7684\u91cf\u5ea6\u6570\u636e\u53ef\u80fd\u975e\u5e38\u56f0\u96be\uff0c\u9700\u8981\u8010\u5fc3\u534f\u8c03\u3002\u5bf9\u6b64\uff0c\u5e94\u8be5\u7ed9\u4e88FDA\u4fe1\u4efb\uff0c\u4ee5\u4fbf\u5176\u5206\u6790\u4e0d\u540c\u60c5\u51b5\u4e0b\u7684\u8d28\u91cf\u91cf\u5ea6\u6307\u6807\u5e76\u8fdb\u884c\u5b9e\u5730\u8003\u5bdf\u3002<\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: normal;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: normal;\">\u5f53\u7136\uff0c\u5982\u679c\u4e0d\u5f3a\u8c03\u7ec4\u7ec7\u5185\u90e8\u7684\u6587\u5316\u56e0\u7d20\uff0c\u4e0d\u5c06\u8d28\u91cf\u7ed3\u679c\u4e0e\u7a33\u5065\u7684\u5353\u8d8a\u751f\u4ea7\u8fc7\u7a0b\u76f8\u8054\u7cfb\uff0c\u4e5f\u4e0d\u4f7f\u7528\u5141\u8bb8\u4e86\u89e3\u60a3\u8005\u98ce\u9669\u7684\u65b9\u5f0f\u67e5\u770b\u6570\u636e\uff0c\u90a3\u4e48\u8ba8\u8bba\u8d28\u91cf\u95ee\u9898\u6beb\u65e0\u610f\u4e49\u3002 \u5bf9\u6b64\uff0cFDA\u518d\u6b21\u91c7\u53d6\u4e86\u6b63\u786e\u7684\u63aa\u65bd\u3002\u76ee\u524d\uff0cFDA\u5df2\u9080\u8bf7\u5723\u52a0\u4ed1\u5927\u5b66\u5ba1\u67e5\u8d28\u91cf\u91cf\u5ea6\u4e0e\u5353\u8d8a\u751f\u4ea7\u8fd0\u8425\u4e4b\u95f4\u7684\u76f8\u5173\u6027\u3002\u6839\u636ethe Pink Sheet\uff08Informa 2018\u5e746\u670815\u65e5\u51fa\u7248\uff09\u62a5\u9053\uff0c\u5723\u52a0\u4ed1\u5927\u5b66\u5df2\u7ecf\u786e\u5b9a\u4e8610\u4e2a\u6210\u719f\u5ea6\u5c5e\u6027\uff0c\u5e76\u53d1\u73b0\uff0c\u201c91%\u7684\u8d28\u91cf\u884c\u4e3a\u53d8\u5f02\u53ef\u4ee5\u7528\u524d10\u4e2a\u8d28\u91cf\u6210\u719f\u5ea6\u5c5e\u6027\u6765\u89e3\u91ca\u3002\u8fd9\u9879\u7814\u7a76\u7ed3\u679c\u5f88\u6709\u610f\u4e49\u3002\u6b64\u5916\uff0cISPE\u5728\u6267\u884c\u4e24\u8f6e\u8d28\u91cf\u91cf\u5ea6\u8bd5\u70b9\u8ba1\u5212\u65b9\u9762\u4e5f\u53d1\u6325\u4e86\u4e3b\u5bfc\u4f5c\u7528\uff0c\u5e76\u63d0\u4f9b\u4e86\u5efa\u8bae\u91cf\u5ea6\u6307\u6807\u548c\u8d28\u91cf\u7ed3\u679c\u4e4b\u95f4\u7684\u6570\u636e\u76f8\u5173\u6027\uff0c\u8fd9\u4e9b\u76f8\u5173\u6027\u5728FDA\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u7684\u5b9e\u65bd\u8fc7\u7a0b\u4e2d\u4e00\u76f4\u88ab\u5f15\u7528\u3002\u7f8e\u56fd\u6ce8\u5c04\u5242\u836f\u7269\u534f\u4f1a\uff08Parenteral Drug Association&nbsp;\uff0cPDA\uff09\u5728\u5236\u5b9a\u6587\u5316\u8bc4\u4f30\u5ba1\u8ba1\u65b9\u6cd5\u65b9\u9762\u53d1\u6325\u91cd\u8981\u4f5c\u7528\uff0c\u4f01\u4e1a\u53ef\u4ee5\u5229\u7528\u8be5\u6587\u5316\u8bc4\u4f30\u65b9\u6cd5\u786e\u5b9a\u7ec4\u7ec7\u6587\u5316\u6210\u719f\u5ea6\uff0c\u8fdb\u800c\u5728\u6301\u7eed\u63a8\u8fdb\u4f18\u8d28\u8d28\u91cf\u6587\u5316\u5b9e\u8df5\u7684\u540c\u65f6\uff0c\u5f00\u59cb\u5236\u5b9a\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\uff0c\u4ee5\u6539\u8fdb\u786e\u4fdd\u4ea7\u54c1\u8d28\u91cf\u7684\u65b9\u6cd5\u3002FDA\u5df2\u4e0ePDA\u5f00\u4f1a\u8ba8\u8bba\u4e86\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u3002<\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: normal;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: normal;\">\u7c7b\u4f3c\u4e8e\u4ea7\u54c1\u751f\u4ea7\uff0c\u7a33\u5065\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7531\u5927\u91cf\u8861\u91cf\u6807\u51c6\u7ec4\u6210\uff0c\u8fd9\u4e9b\u8861\u91cf\u6807\u51c6\u5e76\u975e\u53ea\u6709\u4e00\u79cd\u5f62\u5f0f\uff0c\u800c\u5e94\u88ab\u7b80\u5316\u4e3a\u4e00\u4e2a\u53ef\u8861\u91cf\u7684\u91cf\u5ea6\uff0c\u6216\u5728\u6574\u4e2a\u884c\u4e1a\u4e2d\u8fdb\u884c\u6bd4\u8f83\u3002\u6279\u8bb0\u5f55\u4e0d\u4ec5\u53ef\u7528\u4e8e\u786e\u5b9a\u4ea7\u54c1\u751f\u4ea7\u5de5\u827a\u8fc7\u7a0b\uff0c\u540c\u65f6\u4e5f\u8865\u5145\u8bf4\u660e\u5b9e\u9a8c\u5ba4\u7a0b\u5e8f\u3001\u8c03\u67e5\u3001\u68c0\u67e5\u3001\u751f\u4ea7\u7a0b\u5e8f\u3001\u73b0\u573a\u8bc4\u4f30\uff08gemba 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style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 2.25em;height: 2.25em;border-top-width: 5px;border-top-style: solid;border-top-color: rgb(68, 105, 155);border-left-width: 5px;border-left-style: solid;border-left-color: rgb(68, 105, 155);transform: rotate(0deg);-webkit-transform: rotate(0deg);\"><\/section>\n<section style=\"margin: -2.25em 0px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;background-color: rgb(242, 242, 242);\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: 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break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px 15px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\">2018\u5e747\u670826\u65e5<\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\">\u4f5c\u8005\uff1aJanet Woodcock\u535a\u58eb\u548c Michael Kopcha\u535a\u58eb<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 20px;height: 20px;background-color: rgb(249, 174, 165);\"><\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 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style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: none;min-height: 1em;text-indent: 2em;white-space: normal;\"><strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u8d28\u91cf\u91cf\u5ea6<\/strong>\uff08Quality metrics\uff09\u88ab\u5e94\u7528\u4e8e\u5404\u4e2a\u884c\u4e1a\uff0c\u4ee5\u76d1\u6d4b\u8d28\u91cf\u63a7\u5236\u4f53\u7cfb\u548c\u5de5\u827a\uff0c\u786e\u4fdd\u5176\u7b26\u5408\u6807\u51c6\uff0c\u5e76\u7528\u4e8e\u786e\u5b9a\u6539\u8fdb\u751f\u4ea7\u7684\u65b9\u6cd5\u3002\u5bf9\u5236\u836f\u884c\u4e1a\u6765\u8bf4\uff0c\u8d28\u91cf\u91cf\u5ea6\u7684\u5e94\u7528\u53ef\u4e3a\u60a3\u8005\u3001\u751f\u4ea7\u5546\u4ee5\u53caFDA\u5e26\u6765\u6f5c\u5728\u7684\u6548\u76ca\u2014\u2014\u6bd4\u5982\u80fd\u591f\u66f4\u597d\u5730\u5e94\u5bf9\u836f\u54c1\u77ed\u7f3a\u95ee\u9898\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 20px;height: 20px;float: right;background-color: rgb(249, 174, 165);\"><\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 22px 0px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: bottom;width: 0px;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 0px;border-bottom-width: 24px;border-bottom-style: solid;border-bottom-color: rgb(249, 110, 87);border-left-width: 11px !important;border-left-style: solid !important;border-left-color: transparent !important;border-right-width: 11px !important;border-right-style: solid !important;border-right-color: transparent !important;\"><\/section>\n<section style=\"margin: -21px 1px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 0px;border-bottom-width: 22px;border-bottom-style: solid;border-bottom-color: rgb(255, 255, 255);border-left-width: 10px !important;border-left-style: solid !important;border-left-color: transparent !important;border-right-width: 10px !important;border-right-style: solid !important;border-right-color: transparent !important;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px 0px 10px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: -2px 0px 0px;padding: 10px;border: 1px solid rgb(249, 110, 87);width: 677px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;box-shadow: 3px 3px 5px rgb(204,204,204);background-color: rgb(255, 255, 255);\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: justify;line-height: 1.7;letter-spacing: 1px;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: normal;\">\u6ce8\uff1a<strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\u8d28\u91cf\u91cf\u5ea6<\/strong>\u7814\u7a76\u9879\u76ee\u7684\u76ee\u6807\u662f\u8bc4\u4f30\u4e00\u7ec4\u6f5c\u5728\u8d28\u91cf\u91cf\u5ea6\u4e3a\u5b83\u4eec\u5728\u6574\u4e2a\u5236\u836f\u4e1a\u76d1\u6d4b\u8d28\u91cf\u6548\u7528\u3002\u8be5\u9879\u76ee\u8f85\u52a9FDA\u5411\u7f8e\u56fd\u516c\u4f17\u4fdd\u8bc1\u836f\u54c1\u8d28\u91cf\u76d1\u7763\u4ece\u5b9a\u6027\u5230\u5b9a\u91cf\u7684\u8f6c\u53d8\u548c\u4ee5\u4e13\u4e1a\u77e5\u8bc6\u4e3a\u57fa\u7840\u7684\u8bc4\u4f30\u3002\u8be5\u9879\u76ee\u7684\u6210\u679c\u8fd8\u53ef\u4ee5\u7528\u4e8e\u5e2e\u52a9\u4e3a\u53d1\u5c55\u57fa\u4e8e\u98ce\u9669\u68c0\u67e5\u56fd\u5185\u5916\u5236\u836f\u4e1a\u673a\u6784\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;vertical-align: middle;display: inline-block;\"><img style=\"margin: 0px;padding: 0px;height: auto !important;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;vertical-align: middle;width: 469px !important;visibility: visible !important;\"     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/09\/2-1537164957.jpg\" alt=\"\u7f8e\u56fdFDA\u7684\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u6700\u65b0\u8fdb\u5c55\" title=\"\u7f8e\u56fdFDA\u7684\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u6700\u65b0\u8fdb\u5c55\"  \/><\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\">FDA\u836f\u54c1\u8bc4\u4ef7\u4e0e\u7814\u7a76\u4e2d\u5fc3\u4e3b\u4efb\uff0cJanet 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style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;width: 677px;vertical-align: top;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;vertical-align: middle;display: inline-block;width: 677px;\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" style=\"vertical-align: middle;max-width: 100%;box-sizing: border-box;\" viewbox=\"0 0 303.3 4.6\" x=\"0px\" y=\"0px\" width=\"100%\"><g style=\"box-sizing: border-box;\"><g style=\"box-sizing: border-box;\"><g style=\"box-sizing: border-box;\"><g style=\"box-sizing: border-box;\"><path style=\"box-sizing: border-box;\" fill=\"rgb(204, 146, 94)\" d=\"M 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2.3 Z\"><\/path><\/g><g style=\"box-sizing: border-box;\"><path style=\"box-sizing: border-box;\" fill=\"rgb(204, 146, 94)\" d=\"M 157.8 2.3 c 0 0.6 -0.5 1.1 -1.1 1.1 c -0.6 0 -1.1 -0.5 -1.1 -1.1 c 0 -0.6 0.5 -1.1 1.1 -1.1 C 157.3 1.2 157.8 1.7 157.8 2.3 Z\"><\/path><\/g><g style=\"box-sizing: border-box;\"><path style=\"box-sizing: border-box;\" fill=\"rgb(204, 146, 94)\" d=\"M 153.4 2.3 c 0 0.6 -0.5 1.1 -1.1 1.1 c -0.6 0 -1.1 -0.5 -1.1 -1.1 c 0 -0.6 0.5 -1.1 1.1 -1.1 C 152.9 1.2 153.4 1.7 153.4 2.3 Z\"><\/path><\/g><g style=\"box-sizing: border-box;\"><path style=\"box-sizing: border-box;\" fill=\"rgb(204, 146, 94)\" d=\"M 149 2.3 c 0 0.6 -0.5 1.1 -1.1 1.1 s -1.1 -0.5 -1.1 -1.1 c 0 -0.6 0.5 -1.1 1.1 -1.1 S 149 1.7 149 2.3 Z\"><\/path><\/g><g style=\"box-sizing: border-box;\"><path style=\"box-sizing: border-box;\" fill=\"rgb(204, 146, 94)\" d=\"M 144.5 2.3 c 0 0.6 -0.5 1.1 -1.1 1.1 c -0.6 0 -1.1 -0.5 -1.1 -1.1 c 0 -0.6 0.5 -1.1 1.1 -1.1 C 144.1 1.2 144.5 1.7 144.5 2.3 Z\"><\/path><\/g><g style=\"box-sizing: border-box;\"><path style=\"box-sizing: border-box;\" fill=\"rgb(204, 146, 94)\" d=\"M 140.1 2.3 c 0 0.6 -0.5 1.1 -1.1 1.1 c -0.6 0 -1.1 -0.5 -1.1 -1.1 c 0 -0.6 0.5 -1.1 1.1 -1.1 C 139.7 1.2 140.1 1.7 140.1 2.3 Z\"><\/path><\/g><g style=\"box-sizing: border-box;\"><path style=\"box-sizing: border-box;\" fill=\"rgb(204, 146, 94)\" d=\"M 135.7 2.3 c 0 0.6 -0.5 1.1 -1.1 1.1 s -1.1 -0.5 -1.1 -1.1 c 0 -0.6 0.5 -1.1 1.1 -1.1 S 135.7 1.7 135.7 2.3 Z\"><\/path><\/g><g style=\"box-sizing: border-box;\"><path style=\"box-sizing: border-box;\" fill=\"rgb(204, 146, 94)\" d=\"M 131.3 2.3 c 0 0.6 -0.5 1.1 -1.1 1.1 c -0.6 0 -1.1 -0.5 -1.1 -1.1 c 0 -0.6 0.5 -1.1 1.1 -1.1 C 130.8 1.2 131.3 1.7 131.3 2.3 Z\"><\/path><\/g><\/g><\/svg><\/section>\n<\/section>\n<\/section>\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 20px;height: 20px;background-color: rgb(249, 174, 165);\"><\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;\"><\/section>\n<section style=\"margin: -10px 0px;padding: 0px 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: top;width: 677px;\">\n<section style=\"margin: 0px;padding: 10px;border: 2px solid rgba(255, 255, 255, 0);word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;background-color: rgba(246, 212, 218, 0.580392);\">\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 0px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;font-size: 17px;text-align: justify;line-height: 1.7;color: rgb(110, 110, 110);letter-spacing: 1px;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: none;min-height: 1em;text-indent: 2em;white-space: normal;\">\u57fa\u4e8e\u4ee5\u4e0a\u6548\u76ca\u8003\u8651\uff0cFDA\u5ba3\u5e03\u4e86<strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(253, 68, 39);\">\u4e24\u9879\u65b0\u7684\u81ea\u613f\u8ba1\u5212\u2014\u2014\u8d28\u91cf\u91cf\u5ea6\u53cd\u9988\u8ba1\u5212<\/span><\/strong>\uff08the Quality Metrics Feedback Program\uff09\u548c<strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(253, 68, 39);\">\u8d28\u91cf\u91cf\u5ea6\u73b0\u573a\u8003\u5bdf\u8ba1\u5212<\/span><\/strong>\uff08the Quality Metrics Site Visit Program\uff09\uff0c\u8fd9\u4e24\u9879\u8ba1\u5212\u662f\u5bf9\u5229\u76ca\u76f8\u5173\u65b9\u5c31\u8d28\u91cf\u91cf\u5ea6\u7ee7\u7eed\u52a0\u5f3a\u6c9f\u901a\u8bf7\u6c42\u7684\u56de\u5e94\uff0c\u4e14\u4e3a\u884c\u4e1a\u63d0\u4f9b\u672a\u6765\u8054\u7cfb\u5e76\u544a\u77e5FDA\u8d28\u91cf\u91cf\u5ea6\u5b9e\u65bd\u7ee9\u6548\u7684\u65b9\u6cd5\u3002\u8fd9\u4e24\u9879\u8ba1\u5212\u8fd8\u5c06\u5e2e\u52a9\u5236\u836f\u4f01\u4e1a\u66f4\u597d\u5730\u7406\u89e3\u8d28\u91cf\u91cf\u5ea6\u5e94\u5982\u4f55\u7eb3\u5165\u8d28\u91cf\u6587\u5316\uff0c\u5e76\u652f\u6301\u4ea7\u54c1\u548c\u5de5\u827a\u8d28\u91cf\u7684\u6539\u8fdb\u3002<\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: none;min-height: 1em;text-indent: 2em;white-space: normal;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: none;min-height: 1em;text-indent: 2em;white-space: normal;\">\u65e9\u671f\u5b9e\u65bd\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u4ee5\u89e3\u51b3\u751f\u4ea7\u95ee\u9898\u7684\u751f\u4ea7\u5546\u53cd\u9988\uff0c\u4ee5\u53ca\u7531FDA\u652f\u6301\u7684\u72ec\u7acb\u5b66\u672f\u7814\u7a76\u5747\u8868\u660e\uff0c\u751f\u4ea7\u5546\u7684\u5168\u9762\u8d28\u91cf\u8ba1\u5212\u53d7\u76ca\u4e8e\u8d28\u91cf\u91cf\u5ea6\u7684\u4f7f\u7528\u3002\u8d28\u91cf\u91cf\u5ea6\uff08\u5982\u751f\u4ea7\u6279\u6b21\u56e0\u672a\u8fbe\u5230\u65e2\u5b9a\u8d28\u91cf\u6807\u51c6\u5bfc\u81f4\u7684\u62d2\u7edd\u653e\u884c\u7387\uff09\u53ef\u4ee5\u5e2e\u52a9\u751f\u4ea7\u4f01\u4e1a\u76d1\u63a7\u8d28\u91cf\u63a7\u5236\u4f53\u7cfb\u5e76\u63a8\u8fdb\u6301\u7eed\u6539\u8fdb\u5de5\u4f5c\u3002\u8d28\u91cf\u91cf\u5ea6\u6570\u636e\u53ef\u4ee5\u5e2e\u52a9FDA\u5728\u5b89\u6392\u68c0\u67e5\u65f6\u66f4\u597d\u5730\u8bc4\u4f30\u98ce\u9669\u3002\u8fd9\u6709\u53ef\u80fd\u964d\u4f4eFDA\u5bf9\u8f83\u4f4e\u98ce\u9669\u4f01\u4e1a\u6267\u884c\u76d1\u7763\u68c0\u67e5\u9891\u7387\uff0c\u5e76\u7f29\u5c0f\u6267\u884c\u73b0\u573a\u68c0\u67e5\u7684\u5173\u6ce8\u91cd\u70b9\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 20px;height: 20px;float: right;background-color: rgb(249, 174, 165);\"><\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;border-radius: 0px;border: 0px dotted rgb(62, 62, 62);vertical-align: middle;display: inline-block;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"><\/section>\n<\/section>\n<\/section>\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\">FDA\u836f\u54c1\u8bc4\u4ef7\u4e0e\u7814\u7a76\u4e2d\u5fc3\uff0c\u836f\u54c1\u8d28\u91cf\u529e\u516c\u5ba4\u4e3b\u4efb\uff0cMichael Kopcha\u535a\u58eb\uff0c\u6ce8\u518c\u836f\u5e08<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;width: 677px;vertical-align: top;\">\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 20px;height: 20px;background-color: rgb(249, 174, 165);\"><\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;\"><\/section>\n<section style=\"margin: -10px 0px;padding: 0px 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: top;width: 677px;\">\n<section style=\"margin: 0px;padding: 10px;border: 2px solid rgba(255, 255, 255, 0);word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;background-color: rgba(246, 212, 218, 0.580392);\">\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 0px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;font-size: 17px;text-align: justify;line-height: 1.7;color: rgb(110, 110, 110);letter-spacing: 1px;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: none;min-height: 1em;text-indent: 2em;white-space: normal;\">\u8bb8\u591a\u836f\u54c1\u77ed\u7f3a\u7684\u76f4\u63a5\u539f\u56e0\u90fd\u662f\u8d28\u91cf\u95ee\u9898\uff0c\u5982\u4e0d\u5408\u683c\u7684\u751f\u4ea7\u8bbe\u65bd\u6216\u5de5\u827a\u3002\u8d28\u91cf\u91cf\u5ea6\u6307\u6807\u53ef\u7528\u4e8e\u8bc6\u522b\u6f5c\u5728\u7684\u836f\u54c1\u4f9b\u5e94\u4e2d\u65ad\u60c5\u51b5\uff0c\u4ece\u800c\u6709\u52a9\u4e8e\u7f13\u89e3\u672a\u6765\u53ef\u80fd\u53d1\u751f\u7684\u836f\u54c1\u77ed\u7f3a\u3002\u8fd9\u5c06\u786e\u4fdd\u60a3\u8005\u5728\u9700\u8981\u65f6\u53ef\u4ee5\u83b7\u5f97\u9ad8\u8d28\u91cf\u836f\u54c1\u3002<\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: none;min-height: 1em;text-indent: 2em;white-space: normal;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: none;min-height: 1em;text-indent: 2em;white-space: normal;\">\uff081\uff09<strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(253, 68, 39);\">\u201c\u8d28\u91cf\u91cf\u5ea6\u53cd\u9988\u8ba1\u5212\u201d<\/span><\/strong>\u662f\u6307\u5411\u5df2\u7ecf\u5b9e\u65bd\u548c\u6b63\u5728\u91c7\u7528\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u7684\u751f\u4ea7\u5546\u548c\u53d1\u8d77\u4eba\u5f81\u6c42\u610f\u89c1\u3002FDA\u9f13\u52b1\u6709\u8d44\u683c\u53c2\u52a0<strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">C\u7c7b\u4f1a\u8bae<\/strong>\u7684\u836f\u54c1\u7533\u8bf7\u4eba\u53ca\u7b80\u7565\u65b0\u836f\u7533\u8bf7\uff08ANDA\uff09\u6301\u6709\u4eba\u5411FDA\u63d0\u4ea4\u4f1a\u8bae\u8bf7\u6c42\uff0c\u4ee5\u8ba8\u8bba\u7279\u5b9a\u4ea7\u54c1\u7684\u8d28\u91cf\u91cf\u5ea6\u3002\u4f5c\u4e3a\u53cd\u9988\u8ba1\u5212\u5b9e\u65bd\u5de5\u4f5c\u7684\u4e00\u90e8\u5206\uff0cFDA\u4e5f\u6b63\u5728\u8fdb\u884c\u8bd5\u70b9\u7814\u7a76\uff0c\u4ee5\u4fbf\u4ece\u4e0d\u80fd\u53c2\u52a0\u4ee5\u4e0a\u4f1a\u8bae\u7684\u5176\u4ed6\u7c7b\u578b\u673a\u6784\u83b7\u5f97\u53cd\u9988\uff0c\u5982\u539f\u6599\u836f\u4f9b\u5e94\u5546\u3001\u975e\u5904\u65b9\u836f\u4e13\u8bba\u4ea7\u54c1\u751f\u4ea7\u5546\uff08over-the-counter monograph product establishments\uff09\u548c\u5408\u540c\u751f\u4ea7\u7ec4\u7ec7\uff08CMOs\uff09\u3002<\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: none;min-height: 1em;text-indent: 2em;white-space: normal;\"><br style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: none;min-height: 1em;text-indent: 2em;white-space: normal;\">\uff082\uff09<strong style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\"><span style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;color: rgb(253, 68, 39);\">\u201c\u8d28\u91cf\u91cf\u5ea6\u73b0\u573a\u8003\u5bdf\u8ba1\u5212\u201d<\/span><\/strong>\u7684\u76ee\u7684\u662f\u4e3a\u53c2\u4e0eFDA\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u5236\u5b9a\u7684FDA\u5de5\u4f5c\u4eba\u5458\u63d0\u4f9b\u73b0\u573a\u76f4\u63a5\u5b66\u4e60\u548c\u4ea4\u6d41\u7684\u673a\u4f1a\u3002\u540c\u65f6\uff0c\u8be5\u8ba1\u5212\u4e5f\u5c06\u4e3a\u5229\u76ca\u76f8\u5173\u65b9\u63d0\u4f9b\u673a\u4f1a\uff0c\u4ee5\u4fbf\u4e8e\u89e3\u91ca\u5b9e\u65bd\u548c\u7ba1\u7406\u8d28\u91cf\u91cf\u5ea6\u8ba1\u5212\u8fc7\u7a0b\u4e2d\u6240\u9762\u4e34\u7684\u4f18\u52bf\u548c\u6311\u6218\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 20px;height: 20px;float: right;background-color: rgb(249, 174, 165);\"><\/section>\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 10px 22px 0px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: center;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;display: inline-block;vertical-align: bottom;width: 0px;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 0px;border-bottom-width: 24px;border-bottom-style: solid;border-bottom-color: rgb(249, 110, 87);border-left-width: 11px !important;border-left-style: solid !important;border-left-color: transparent !important;border-right-width: 11px !important;border-right-style: solid !important;border-right-color: transparent !important;\"><\/section>\n<section style=\"margin: -21px 1px 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;width: 0px;border-bottom-width: 22px;border-bottom-style: solid;border-bottom-color: rgb(255, 255, 255);border-left-width: 10px !important;border-left-style: solid !important;border-left-color: transparent !important;border-right-width: 10px !important;border-right-style: solid !important;border-right-color: transparent !important;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px 0px 10px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: -2px 0px 0px;padding: 10px;border: 1px solid rgb(249, 110, 87);width: 677px;word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;box-shadow: 2.82px 2.82px 5px rgb(204,204,204);background-color: rgb(255, 255, 255);\">\n<section class=\"V5\" style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\" >\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;text-align: justify;line-height: 1.7;letter-spacing: 1px;\">\n<p style=\"margin: 0px;padding: 0px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;clear: both;min-height: 1em;text-indent: 2em;white-space: 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