{"id":806,"date":"2014-07-01T01:56:39","date_gmt":"2014-07-01T01:56:39","guid":{"rendered":"http:\/\/www.wi.rwth-aachen.de\/SmartMedCN\/?p=806"},"modified":"2014-07-01T01:56:39","modified_gmt":"2014-07-01T01:56:39","slug":"fda-orders-glaxosmithkline-to-review-manufacturing-worldwide","status":"publish","type":"post","link":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/2014\/07\/01\/fda-orders-glaxosmithkline-to-review-manufacturing-worldwide\/","title":{"rendered":"FDA Orders GSK to Review Manufacturing Worldwide"},"content":{"rendered":"<p><strong>The US Food and Drug Administration has ordered GlaxoSmithKline to review its manufacturing operations globally after finding that its Canadian subsidiary violated quality requirements during the manufacture of its flu vaccine FluLaval. (Source: The Guardian)<\/strong><\/p>\n<h3>FDA\u52d2\u4ee4\u845b\u5170\u7d20\u53f2\u514b\u68c0\u67e5\u5176\u5168\u7403\u751f\u4ea7\u4e1a\u52a1<\/h3>\n<p>\u6765\u6e90\uff1a\u534e\u5c14\u8857\u65e5\u62a5<\/p>\n<p>\u6838\u5fc3\u63d0\u793a\uff1a\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40(Food and Drug Administration, \u7b80\u79f0FDA)\u5df2\u4e0b\u4ee4\u845b\u5170\u7d20\u53f2\u514b(Glaxosmithkline plc, GSK, GSK.LN)\u68c0\u67e5\u5176\u5168\u7403\u751f\u4ea7\u4e1a\u52a1\uff0c\u56e0\u4e3a\u53d1\u73b0\u5176\u52a0\u62ff\u5927\u9644\u5c5e\u516c\u53f8\u5728\u751f\u4ea7\u6d41\u611f\u75ab\u82d7FluLaval\u7684\u8fc7\u7a0b\u4e2d\u8fdd\u53cd\u4e86\u8d28\u91cf\u89c4\u5b9a\u3002<\/p>\n<p>\u82f1\u56fd\u300a\u536b\u62a5\u300b(The Guardian)\u5468\u4e09\u5728\u5176\u7f51\u7ad9\u4e0a\u62a5\u9053\uff0c\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40(Food and Drug Administration, \u7b80\u79f0FDA)\u5df2\u4e0b\u4ee4\u845b\u5170\u7d20\u53f2\u514b(Glaxosmithkline plc, GSK, GSK.LN)\u68c0\u67e5\u5176\u5168\u7403\u751f\u4ea7\u4e1a\u52a1\uff0c\u56e0\u4e3a\u53d1\u73b0\u5176\u52a0\u62ff\u5927\u9644\u5c5e\u516c\u53f8\u5728\u751f\u4ea7\u6d41\u611f\u75ab\u82d7FluLaval\u7684\u8fc7\u7a0b\u4e2d\u8fdd\u53cd\u4e86\u8d28\u91cf\u89c4\u5b9a\u3002<\/p>\n<p>\u62a5\u9053\u79f0\uff0cFDA\u7684\u547d\u4ee4\u8ba9\u845b\u5170\u7d20\u53f2\u514b\u53c8\u4e00\u6b21\u53d7\u5230\u91cd\u521b\uff0c\u8fd9\u5bb6\u82f1\u56fd\u6700\u5927\u7684\u5236\u836f\u4f01\u4e1a\u5df2\u7ecf\u5728\u6ce2\u5170\u3001\u4f0a\u62c9\u514b\u3001\u7ea6\u65e6\u3001\u9ece\u5df4\u5ae9\u548c\u4e2d\u56fd\u9762\u4e34\u8150\u8d25\u6307\u63a7\uff0c\u800c\u4e14\u82f1\u56fd\u91cd\u5927\u6b3a\u8bc8\u72af\u7f6a\u4fa6\u67e5\u7f72(Serious Fraud Office)\u6b63\u5728\u5bf9\u8be5\u516c\u53f8\u7684\u9500\u552e\u64cd\u4f5c\u8fdb\u884c\u5211\u4e8b\u8c03\u67e5\u3002<\/p>\n<p>\u300a\u536b\u62a5\u300b\u79f0\uff0cFDA\u5728\u53d1\u7ed9\u845b\u5170\u7d20\u53f2\u514b\u7684\u8b66\u544a\u4fe1\u4e2d\u6307\u51fa\uff0c\u845b\u5170\u7d20\u53f2\u514b\u4f4d\u4e8e\u9b41\u5317\u514b\u7684\u9644\u5c5e\u516c\u53f8ID Biomedical\u751f\u4ea7FluLaval\u7684\u64cd\u4f5c\u4e0d\u7b26\u5408\u826f\u597d\u751f\u4ea7\u89c4\u8303\u3002ID Biomedical\u751f\u4ea7\u7684\u8be5\u6d41\u611f\u75ab\u82d7\u4f9b\u5e94\u52a0\u62ff\u5927\u548c\u7f8e\u56fd\u5e02\u573a\u3002<\/p>\n<p>\u62a5\u9053\u6307\u51fa\uff0cFDA\u5728\u4fe1\u4e2d\u79f04\u6708\u4efd\u68c0\u67e5ID Biomedical\u4f4d\u4e8e\u9b41\u5317\u514bSainte-Foy\u7684\u5236\u836f\u5382\u65f6\uff0c\u53d1\u73b0\u5de5\u5382\u672a\u91c7\u53d6\u9002\u5f53\u63aa\u65bd\u9632\u6b62\u836f\u54c1\u88ab\u5fae\u751f\u7269\u6c61\u67d3\uff0c\u800c\u5de5\u5382\u58f0\u79f0\u662f\u65e0\u83cc\u5316\u64cd\u4f5c\u3002FDA\u8fd8\u53d1\u73b0\u5de5\u5382\u5185\u7684\u7eaf\u5316\u6c34\u7cfb\u7edf\u4e0d\u8db3\u4ee5\u9632\u6b62\u6c61\u67d3\u3002\u8be5\u5382\u5171\u6709\u5458\u5de5600\u4eba\u3002<\/p>\n<p>Tags\uff1aFDA \u845b\u5170\u7d20\u53f2\u514b \u5168\u7403\u751f\u4ea7\u4e1a\u52a1<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The US Food and Drug Administration has ordered GlaxoSmithKline to review its manufacturing operations globally after finding that its Canadian subsidiary violated quality requirements during the manufacture of its flu [&hellip;]<\/p>\n","protected":false},"author":951,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"c2c_always_allow_admin_comments":false,"footnotes":""},"categories":[2,5],"tags":[13,17],"class_list":["post-806","post","type-post","status-publish","format-standard","hentry","category-government-news","category-pharmaceutical-company-news","tag-drug-saftey","tag-government-supervision"],"_links":{"self":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/806","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/users\/951"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/comments?post=806"}],"version-history":[{"count":0,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/posts\/806\/revisions"}],"wp:attachment":[{"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/media?parent=806"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/categories?post=806"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.rwth-aachen.de\/smartmedcn\/wp-json\/wp\/v2\/tags?post=806"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}