{"id":9616,"date":"2018-06-13T01:00:00","date_gmt":"2018-07-27T09:40:27","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/fda%e4%bb%a5%e6%82%a3%e8%80%85%e4%b8%ba%e4%b8%ad%e5%bf%83-%e6%96%b0%e8%8d%af%e5%ae%a1%e6%89%b92-0%e9%80%9f%e6%9d%a5%e5%88%92%e9%87%8d%e7%82%b9\/"},"modified":"2018-07-27T17:40:28","modified_gmt":"2018-07-27T09:40:28","slug":"fda%e4%bb%a5%e6%82%a3%e8%80%85%e4%b8%ba%e4%b8%ad%e5%bf%83-%e6%96%b0%e8%8d%af%e5%ae%a1%e6%89%b92-0%e9%80%9f%e6%9d%a5%e5%88%92%e9%87%8d%e7%82%b9","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/9616\/","title":{"rendered":"FDA\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3 \u65b0\u836f\u5ba1\u62792.0\u901f\u6765\u5212\u91cd\u70b9"},"content":{"rendered":"
\n

\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40FDA\u53d1\u5e03\u6700\u65b0\u6307\u5357\u8349\u6848\uff0c\u6b63\u5f0f\u8fdb\u5165\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u65b0\u836f\u5f00\u53d12.0\u65f6\u4ee3\u3002<\/span><\/p>\n


<\/p>\n

\u8fd9\u4e2a\u65b0\u836f\u76d1\u7ba1\u6307\u5357\u957f\u5565\u6837\uff1f<\/span><\/p>\n


<\/p>\n

\u4e00\u53e5\u8bdd\uff0c\u90a3\u5c31\u662f\uff1a \u6536\u96c6\u5168\u9762\u548c\u6709\u4ee3\u8868\u6027<\/span>\u7684\u53cd\u9988, \u6536\u96c6\u75c5\u4eba\u7ecf\u9a8c\u7684\u4ee3\u8868\u4fe1\u606f\u7684\u62bd\u6837\u65b9\u6cd5, \u6765\u5f00\u53d1\u548c\u5ba1\u8bc4\u65b0\u836f\uff0c\u5e76\u8d2f\u7a7f\u4ea7\u54c1\u7684\u6574\u4e2a\u751f\u547d\u5468\u671f<\/span>\u3002<\/span><\/p>\n


<\/p>\n

\u5177\u4f53\u6765\u8bf4\uff0c\u8fd9\u4e2a\u65b0\u836f\u5ba1\u62792.0\u6709\u4ee5\u4e0b\u4e09\u4e2a\u91cd\u70b9\uff1a<\/span><\/p>\n


<\/p>\n

1. \u80bf\u7624\u65b0\u836f\u66ff\u4ee3\u7ec8\u70b9<\/span><\/strong><\/span><\/p>\n


<\/p>\n

\u201c\u6211\u4eec\u542c\u5230\u7684\u4fe1\u606f\u662f, \u80bf\u7624\u4ea7\u54c1\u7684\u66f4\u52a0\u73b0\u4ee3\u5316\u7684\u6279\u51c6\u7ec8\u70b9\u662f\u5fc5\u8981\u7684\u3002\u56e0\u4e3a\u8bb8\u591a\u65e7\u7684\u65b9\u6cd5, \u4e34\u5e8a\u8bd5\u9a8c\u7684\u62db\u52df\u548c\u8bbe\u8ba1\u8ffd\u6eaf\u5230\u4e00\u4e2a\u7ec4\u5408\u7ec6\u80de\u6bd2\u6027\u7684\u5316\u7597\u7684\u65f6\u4ee3, \u5176\u4e2d\u60a3\u8005\u63a5\u89e6\u5230\u663e\u8457\u7684\u6cbb\u7597\u6bd2\u6027\u3002\u201dFDA\u5728\u65b0\u95fb\u7a3f\u4e2d\u8868\u793a\u3002<\/span><\/p>\n


<\/p>\n

\u201c\u8fd9\u4e9b\u7597\u6cd5\u6709\u65f6\u53ea\u63d0\u4f9b\u4e86\u8f7b\u5fae\u7684\u7597\u6548, \u4f46\u662f\u5e26\u6765\u4e86\u4e25\u91cd\u7684\u526f\u4f5c\u7528\u3002\u201d<\/span><\/p>\n


<\/p>\n

\u56e0\u6b64, FDA\u8868\u793a\uff0c\u8bd5\u9a8c\u4e2d\u4f7f\u7528\u7684\u8bc4\u4f30\u7ec8\u70b9, \u5e94\u8be5\u62b5\u6d88\u8fd9\u4e9b\u836f\u7269\u6240\u6784\u6210\u7684\u91cd\u5927\u98ce\u9669<\/span>\u3002<\/span><\/p>\n


<\/p>\n

\u7136\u800c, \u65b0\u7684\u548c\u66f4\u6709\u9488\u5bf9\u6027\u7684\u6cbb\u7597\u65b9\u6cd5\u6709\u4e0d\u540c\u7684\u4f5c\u7528\u673a\u5236\u3002<\/span><\/p>\n


<\/p>\n

\u201c\u66f4\u591a\u7684\u5b9e\u4f8b\u663e\u793a, \u5728\u7cbe\u5fc3\u6311\u9009\u7684\u75c5\u4eba\u4e2d, \u66f4\u9ad8\u7684\u6536\u76ca\u7387, \u5e76\u5f80\u5f80\u663e\u793a\u51cf\u5c11\u6bd2\u6027-\u5728\u66f4\u5c0f\u7684\u4eba\u7fa4, \u6709\u53ef\u80fd\u4f1a\u7528\u4e00\u4e2a\u6807\u8bb0\u7269, \u6765\u9884\u6d4b\u4e34\u5e8a\u53cd\u5e94<\/span>\u3002\u201d<\/span><\/p>\n


<\/p>\n

\u201c\u5728\u8fd9\u4e9b\u60c5\u51b5\u4e0b, \u66ff\u4ee3\u7ec8\u7ed3\u70b9-\u6216\u4e2d\u95f4\u4e34\u5e8a\u5229\u76ca\u7684\u63aa\u65bd-\u53ef\u4ee5\u662f\u4e34\u5e8a\u76f8\u5173\u548c\u9ad8\u5ea6\u91cd\u89c6\u7684\u75c5\u4eba\u3002\u8fd9\u4e9b\u63aa\u65bd\u53ef\u80fd\u5305\u62ec\u5b9e\u4f53\u80bf\u7624\u7684\u5ba2\u89c2\u53cd\u5e94\u7387\uff08OR\uff09\u6216\u65e0\u8fdb\u5c55\u751f\u5b58\uff08PFS\uff09<\/span>, \u6216 \u8840\u6db2\u764c\u7684\u7ec6\u80de\u6027\u53cd\u5e94\u7387\uff08CRR\uff09\u548c\u75be\u75c5\u7684\u6700\u5c0f\u6b8b\u7559\uff08MRD<\/span>\uff09\uff0c\u201dFDA\u6307\u51fa\u3002<\/span><\/p>\n


<\/p>\n

2. \u503e\u542c\u60a3\u8005<\/strong><\/span><\/p>\n


<\/p>\n

\u65b0\u836f\u76d1\u7ba1\u8005\u9700\u8981\u901a\u8fc7\u79d1\u5b66\u8fdb\u6b65\u6765\u5b66\u4e60, \u4e5f\u9700\u8981\u901a\u8fc7\u503e\u542c\u75c5\u4eba\u7684\u4eb2\u8eab\u7ecf\u9a8c\u6765\u5b66\u4e60\u3002<\/span><\/p>\n


<\/p>\n

\u201c\u6211\u4eec\u7684\u5de5\u4f5c\u8981\u6c42\u6211\u4eec\u5fc5\u987b\u7ee7\u7eed\u601d\u8003\uff1a\u5982\u4f55\u4f7f\u836f\u7269\u5f00\u53d1\u7684\u79d1\u5b66\u548c\u5ba1\u67e5\u66f4\u73b0\u4ee3\u548c\u66f4\u6709\u8010\u5fc3, \u4f7f\u6279\u51c6\u7684\u4ea7\u54c1\u80fd\u7ed9\u73b0\u5b9e\u4e16\u754c\u7684\u75c5\u4eba\u548c\u5bb6\u5ead\u6700\u770b\u91cd\u7684\u4ef7\u503c\u6700\u5927\u5316\u3002\u201dFDA\u8868\u793a\u3002<\/span><\/p>\n


<\/p>\n

\u201c\u8fd9\u9700\u8981\u4e0e\u75c5\u4eba\u793e\u533a\u8fdb\u884c\u6301\u7eed\u7684\u63a5\u89e6<\/span>\u3002\u505a\u5f97\u597d, \u7ed3\u679c\u662f\u6211\u4eec\u5ba1\u6279\u65b0\u7684\u533b\u7597\u4ea7\u54c1\u8d8a\u6765\u8d8a\u591a\u53d7\u76ca\u4e8e\u66f4\u597d\u5730\u4e86\u89e3\u75c5\u4eba\u7684\u7ecf\u9a8c, \u4e3a\u6211\u4eec\u7684\u836f\u5ba1\u4eba\u5458\u63d0\u4f9b\u4e86\u4e25\u91cd\u75be\u75c5\u7684\u80cc\u666f, \u5e76\u5e2e\u52a9\u4ed6\u4eec\u4e86\u89e3\u5bf9\u4e8e\u60a3\u8005\u6709\u5173\u7684\u4ec0\u4e48\u662f\u6700\u91cd\u8981\u7684\uff0c\u5176\u4e2d\u5305\u62ec\u6cbb\u7597\u7684\u597d\u5904\u3001\u98ce\u9669\u548c\u75be\u75c5\u8d1f\u62c5\u3002\u201d<\/span><\/p>\n


<\/p>\n

3. \u7eb3\u5165\u60a3\u8005\u610f\u89c1\u7684\u836f\u7269\u5f00\u53d1<\/strong><\/span><\/p>\n


<\/p>\n

FDA \u5df2\u4f18\u5148\u4e0e\u516c\u53f8\u548c\u5176\u4ed6\u5229\u76ca\u76f8\u5173\u8005\u5408\u4f5c, \u6536\u96c6\u75c5\u4eba\u5173\u4e8e\u4ed6\u4eec\u7684\u610f\u89c1\u548c\u9700\u8981\u7684\u4fe1\u606f, \u4ee5\u53ca\u5efa\u7acb\u5fc5\u8981\u7684\u5de5\u5177\u6765\u83b7\u5f97\u75c5\u4eba\u7684\u610f\u89c1\uff0c\u5e76\u63d0\u4f9b\u6709\u610f\u4e49\u7684\u6570\u636e\u3002<\/span><\/p>\n


<\/p>\n

\u5230\u76ee\u524d\u4e3a\u6b62, FDA \u5df2\u572820\u591a\u4e2a\u75be\u75c5\u9886\u57df\u4e3e\u884c\u4e86\u4ee5\u75c5\u4eba\u4e3a\u91cd\u70b9\u7684\u836f\u7269\u5f00\u53d1 (PFDD) \u4f1a\u8bae\u3002<\/span><\/p>\n


<\/p>\n

\u5176\u4e2d\u5305\u62ec\u963f\u7247\u7c7b\u836f\u7269\u6ee5\u7528, \u81ea\u95ed\u75c7, HIV\u75c5\u6bd2\u611f\u67d3, \u5e15\u91d1\u68ee\u6c0f\u75c7\u548c\u5404\u79cd\u7c7b\u578b\u7684\u75bc\u75db\u75c7<\/span>\u3002<\/span><\/p>\n


<\/p>\n

\u8fd9\u4e9b\u4f1a\u8bae\u8ba9 FDA \u7684\u4e13\u4e1a\u5de5\u4f5c\u4eba\u5458\u5bf9\u75c5\u4eba\u548c\u7167\u987e\u8005\u7684\u7ecf\u9a8c\u6709\u4e86\u66f4\u6df1\u7684\u4e86\u89e3\u3002<\/span><\/p>\n


<\/p>\n

\u540c\u6837\u91cd\u8981\u7684\u662f, \u8fd9\u9879\u5de5\u4f5c\u6559\u80b2\u4f01\u4e1a\u5728\u4ea7\u54c1\u5f00\u53d1\u4e2d\u5982\u4f55\u4ee5\u4e25\u683c\u7684\u65b9\u6cd5, \u6765\u83b7\u53d6\u548c\u7eb3\u5165\u8fd9\u4e00\u91cd\u8981\u7684\u548c\u72ec\u7279\u7684\u6295\u5165\u3002<\/span><\/p>\n


<\/p>\n

\u201c\u6211\u4eec\u8fd8\u5fc5\u987b\u89e3\u91ca , FDA \u5c06\u5982\u4f55\u5c06\u8fd9\u4e9b\u4fe1\u606f\u7eb3\u5165\u6211\u4eec\u7684\u76d1\u7ba1\u51b3\u7b56\u4e2d\u3002\u201d<\/span><\/p>\n


<\/p>\n

\u8fd9\u4e2a\u65b0\u7684\u6307\u5357\u8349\u6848\u5c06\u6b63\u5f0f\u544a\u77e5\u75c5\u4eba\u548c\u4ea7\u54c1\u5f00\u53d1\u5546\u8fd9\u4e9b\u539f\u5219\u3002<\/span><\/p>\n


<\/p>\n

\u201c\u8fd9\u5957\u6307\u5bfc\u63cf\u8ff0\u4e86\u5982\u4f55\u6536\u96c6\u60a3\u8005\u7ecf\u9a8c\u6570\u636e\u548c\u75c5\u4eba\u548c\u62a4\u7406\u4eba\u5458\u7684\u5176\u4ed6\u76f8\u5173\u4fe1\u606f, \u7528\u4e8e\u533b\u7597\u4ea7\u54c1\u5f00\u53d1\u548c\u76d1\u7ba1\u51b3\u7b56\u3002\u201dFDA\u603b\u7ed3\u9053\u3002<\/span><\/p>\n


<\/p>\n

FDA\u65b0\u95fb\u7a3f<\/strong>\uff1a<\/span><\/p>\n

https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm610509.htm<\/span><\/p>\n


<\/p>\n

\u4f60\u53ef\u80fd\u559c\u6b22<\/strong>\uff1a<\/span><\/p>\n

\u5267\u900f\uff1a\u8fd9\u4e2a\u624b\u518c\u544a\u8bc9\u4f60 FDA\u600e\u6837\u68c0\u67e5\u836f\u4f01\u68b0\u4f01<\/span><\/a><\/p>\n

FDA\u5c40\u957f\u201d\u5450\u7f55\u201d\uff1a\u4e3a\u9f13\u52b1\u65b0\u836f\u91c7\u53d6\u884c\u52a8<\/span><\/a>
<\/p>\n

\u513f\u7ae5\u7f55\u89c1\u75c5\u65b0\u836f\u5982\u4f55\u63d0\u901f\uff1fFDA\u6307\u5bfc \u591a\u65b9\u53c2\u4e0e<\/span><\/a>
<\/p>\n

\u6ef4\u8840\u67e5\u764c\u6709\u65b0\u653f FDA\u8981\u514d\u57fa\u56e0\u6d4b\u5e8f\u4e0a\u5e02\u524d\u5ba1\u6279<\/span><\/a>
<\/p>\n

\u836f\u4ef7\u9ad8\u5f97\u79bb\u8c31 FDA\u5c40\u957f\u98de\u5200\u4fee\u6539\u5ba1\u6279\u6d41\u7a0b<\/span><\/a>
<\/p>\n


<\/p>\n

\u670d\u52a1\u65b0\u836f\u7814\u53d1 \u628a\u63e1\u6295\u8d44\u8d8b\u52bf<\/span><\/em><\/span><\/p>\n

\u6bcf\u5929\u7528\u65b0\u8bf4\u8bdd \u51b3\u7b56\u4e0d\u53ef\u6216\u7f3a<\/span><\/em><\/span><\/p>\n

\u5065\u70b9\u5b50ihealth<\/em><\/strong>\u662f\u533b\u836f\u884c\u4e1a\u9886\u5148\u7684\u6295\u8d44\u987e\u95ee\u8d44\u8baf\u5e73\u53f0\uff0c\u4e13\u6ce8<\/em>\u7f55\u89c1\u75c5\uff0c<\/strong>\u751f\u7269\u7c7b\u4f3c\u836f\uff0c<\/strong><\/em>\u65e5\u97e9\u5370\u5ea6<\/strong><\/em>\u5065\u5eb7\u884c\u4e1a\u7684\u6700\u65b0\u52a8\u5411\u3002<\/em><\/span><\/p>\n

\u8054\u7cfb\u6211\u4eec\u3002\u8bf7\u53d1\u7535\u90ae\uff1ahxyang_98@hotmail.com<\/span>.<\/em><\/span><\/p>\n

\u4f60\u4e5f\u53ef\u4ee5\u5728\u4efb\u4f55\u5065\u70b9\u5b50\u6587\u7ae0\u540e\u7559\u8a00\u3002\u8bf7\u7b80\u77ed\u8bf4\u660e\u5177\u4f53\u9700\u6c42\u3002\u6211\u4eec\u4e00\u822c\u572824\u5c0f\u65f6\u4e4b\u5185\u8054\u7cfb\u3002<\/em><\/span><\/p>\n

<\/em><\/span><\/p>\n

\n

\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u5065\u70b9\u5b50ihealth <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40FDA\u53d1\u5e03\u6700\u65b0\u6307\u5357\u8349\u6848\uff0c\u6b63\u5f0f\u8fdb\u5165\u4ee5\u60a3\u8005\u4e3a\u4e2d\u5fc3\u7684\u65b0\u836f\u5f00\u53d12.0\u65f6\u4ee3\u3002 \u8fd9\u4e2a\u65b0\u836f\u76d1\u7ba1\u6307\u5357\u957f\u5565 […]<\/p>\n","protected":false},"author":1,"featured_media":9617,"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\/9616"}],"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=9616"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9616\/revisions"}],"predecessor-version":[{"id":9618,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/9616\/revisions\/9618"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/9617"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=9616"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=9616"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=9616"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}