{"id":17001,"date":"2025-05-07T11:39:16","date_gmt":"2025-05-07T03:39:16","guid":{"rendered":"https:\/\/greenoo.tw\/?p=17001"},"modified":"2025-05-07T11:39:16","modified_gmt":"2025-05-07T03:39:16","slug":"fda%e6%aa%a2%e6%9f%a5%e4%b8%89%e5%a4%a7%e6%96%87%e4%bb%b6%e5%a4%a7%e8%a7%a3%e6%9e%90%ef%bc%9a483%e8%a1%a8%e6%a0%bc%e3%80%81eir%e8%88%87%e8%ad%a6%e5%91%8a%e4%bf%a1%e7%9a%84%e9%97%9c%e9%8d%b5%e5%b7%ae","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/fda%e6%aa%a2%e6%9f%a5%e4%b8%89%e5%a4%a7%e6%96%87%e4%bb%b6%e5%a4%a7%e8%a7%a3%e6%9e%90%ef%bc%9a483%e8%a1%a8%e6%a0%bc%e3%80%81eir%e8%88%87%e8%ad%a6%e5%91%8a%e4%bf%a1%e7%9a%84%e9%97%9c%e9%8d%b5%e5%b7%ae\/","title":{"rendered":"FDA\u6aa2\u67e5\u4e09\u5927\u6587\u4ef6\u5927\u89e3\u6790\uff1a483\u8868\u683c\u3001EIR\u8207\u8b66\u544a\u4fe1\u7684\u95dc\u9375\u5dee\u7570"},"content":{"rendered":"<h1>FDA\u6aa2\u67e5\u4e09\u5927\u6587\u4ef6\u5927\u89e3\u6790\uff1a483\u8868\u683c\u3001EIR\u8207\u8b66\u544a\u4fe1\u7684\u95dc\u9375\u5dee\u7570<\/h1>\n<p>\u4e09\u53e5\u8a71\u5fb9\u5e95\u89e3\u6c7aFDA\u6aa2\u67e5\u6587\u4ef6\u7591\u60d1\uff01\u5c0d\u65bc\u8a08\u5283\u9032\u8ecd\u7f8e\u570b\u5e02\u5834\u7684\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u4f86\u8aaa\uff0c\u4e86\u89e3FDA\u7684\u6aa2\u67e5\u6587\u4ef6\u81f3\u95dc\u91cd\u8981\u3002\u9019\u7bc7\u6587\u7ae0\u5c07\u70ba\u4f60\u63ed\u958b483\u8868\u683c\u3001EIR\u548c\u8b66\u544a\u4fe1\u7684\u795e\u79d8\u9762\u7d17\uff0c\u52a9\u4f60\u907f\u958b\u5408\u898f\u9677\u9631\uff01<\/p>\n<h2>\u4e00\u3001FDA 483\u8868\u683c\uff1a\u4e0d\u5408\u898f\u7684\u7b2c\u4e00\u9053\u8b66\u8a0a<\/h2>\n<p>FDA 483\u8868\u683c\u662f\u4ec0\u9ebc\uff1f\u5b83\u662fFDA\u6aa2\u67e5\u5b98\u5728\u73fe\u5834\u6aa2\u67e5\u904e\u7a0b\u4e2d\uff0c\u6839\u64dacGMP\u898f\u7bc4\u767c\u73fe\u7684\u4e0d\u7b26\u5408\u9805\u6e05\u55ae\u3002\u5c31\u50cf\u662f\u4e00\u4efd\u300c\u554f\u984c\u6e05\u55ae\u300d\uff0c\u544a\u8a34\u4f60\u54ea\u4e9b\u5730\u65b9\u9700\u8981\u6539\u9032\u3002<\/p>\n<p>\u6700\u5927\u7684\u554f\u984c\u5c31\u662f\uff0c\u6536\u5230Form 483\u5f8c\uff0c\u4f01\u696d\u50c5\u670915\u5929\u7684\u6574\u6539\u671f\u9650\uff01\u5982\u679c\u7121\u6cd5\u5728\u671f\u9650\u5167\u5b8c\u6210\u6574\u6539\uff0cFDA\u53ef\u80fd\u6703\u63a1\u53d6\u66f4\u56b4\u53b2\u7684\u63aa\u65bd\uff0c\u5305\u62ec\u7d44\u7e54\u4e8c\u6b21\u9a57\u5ee0\u3001\u8981\u6c42\u7522\u54c1\u53ec\u56de\uff0c\u751a\u81f3\u5c07\u4f01\u696d\u5217\u5165\u9ed1\u540d\u55ae\u3002<\/p>\n<h2>\u4e8c\u3001\u5de5\u5ee0\u8abf\u67e5\u5831\u544a(EIR)\uff1a\u6aa2\u67e5\u7684\u5b8c\u6574\u8a18\u9304<\/h2>\n<p>\u9664\u4e86483\u8868\u683c\u5916\uff0cFDA\u6aa2\u67e5\u5b98\u9084\u6703\u88fd\u4f5c\u5de5\u5ee0\u8abf\u67e5\u5831\u544a(EIR)\u3002\u9019\u4efd\u5831\u544a\u901a\u5e38\u572830\u500b\u5de5\u4f5c\u65e5\u5167\u5b8c\u6210\uff0c\u4e26\u7531FDA\u8fa6\u516c\u5ba4\u8ca0\u8cac\u4eba\u5be9\u6838\u3002<\/p>\n<p>\u6839\u64da\u6aa2\u67e5\u7d50\u679c\uff0cEIR\u6703\u88ab\u5206\u70ba\u4e09\u7a2e\u4e0d\u540c\u7684\u72c0\u614b\uff1a<\/p>\n<ul>\n<li>NAI\uff1a\u4e0d\u9700\u63a1\u53d6\u63aa\u65bd \u2013 \u6aa2\u67e5\u671f\u9593\u6c92\u6709\u767c\u73fe\u9055\u898f\u9805\u76ee<\/li>\n<li>VAI\uff1a\u81ea\u9858\u63a1\u53d6\u63aa\u65bd \u2013 \u767c\u73fe\u4e86\u9055\u898f\u9805\u76ee\uff0c\u4f46\u4e0d\u9700\u8981\u5b98\u65b9\u63a1\u53d6\u884c\u52d5<\/li>\n<li>OAI\uff1a\u5b98\u65b9\u9700\u63a1\u53d6\u884c\u52d5 \u2013 \u767c\u73fe\u56b4\u91cd\u9055\u898f\u9805\u76ee\uff0c\u9700\u8981\u63a1\u53d6\u9032\u4e00\u6b65\u6cd5\u898f\u63aa\u65bd<\/li>\n<\/ul>\n<h2>\u4e09\u3001\u8b66\u544a\u4fe1(Warning Letter)\uff1a\u56b4\u91cd\u9055\u898f\u7684\u6b63\u5f0f\u901a\u77e5<\/h2>\n<p>\u800c\u73fe\u5728\uff0c\u6709\u4e9b\u4f01\u696d\u751a\u81f3\u6703\u6536\u5230\u66f4\u56b4\u91cd\u7684\u8b66\u544a\u4fe1\u3002\u7576FDA\u5728\u6aa2\u67e5\u904e\u7a0b\u4e2d\u767c\u73fe\u56b4\u91cd\u7f3a\u9677\uff0c\u4e14\u4f01\u696d\u5c0d483\u8868\u683c\u7684\u56de\u8986\u88ab\u8a8d\u70ba\u4e0d\u5145\u5206\u6642\uff0cFDA\u5c07\u7c3d\u767c\u8b66\u544a\u4fe1\u3002<\/p>\n<p>\u4f01\u696d\u9700\u572815\u500b\u5de5\u4f5c\u65e5\u5167\u56de\u61c9\u8b66\u544a\u4fe1\uff0c\u8a73\u8ff0\u5982\u4f55\u89e3\u6c7a\u6240\u6d89\u7f3a\u9677\u53ca\u9632\u6b62\u518d\u6b21\u767c\u751f\u7684\u63aa\u65bd\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u9019\u4e9b\u8b66\u544a\u4fe1\u901a\u5e38\u6703\u5728FDA\u5b98\u65b9\u7db2\u7ad9\u4e0a\u516c\u958b\uff0c\u5c0d\u4f01\u696d\u8072\u8b7d\u9020\u6210\u56b4\u91cd\u5f71\u97ff\uff01<\/p>\n<p>\u5c0d\u65bc\u6e96\u5099\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u53f0\u7063\u88fd\u9020\u5546\u548c\u8de8\u5883\u96fb\u5546\u8ce3\u5bb6\uff0c\u4e86\u89e3\u9019\u4e9bFDA\u6aa2\u67e5\u6587\u4ef6\u7684\u5340\u5225\u548c\u61c9\u5c0d\u7b56\u7565\u81f3\u95dc\u91cd\u8981\u3002\u53ca\u65e9\u898f\u5283\u3001\u56b4\u683c\u9075\u5b88FDA\u898f\u7bc4\uff0c\u624d\u80fd\u78ba\u4fdd\u7522\u54c1\u9806\u5229\u9032\u5165\u7f8e\u570b\u5e02\u5834\uff01<\/p>\n<p>\u6709\u4efb\u4f55\u554f\u984c\u60f3\u5373\u6642\u89e3\u7b54\uff1f\u5225\u7336\u8c6b\uff0c\u99ac\u4e0a\u6dfb\u52a0\u6211\u5011\u7684LINE\uff0c\u7da0\u5708\u5708\u7b49\u4f60\u4f86\uff1a<a href=\"https:\/\/line.me\/ti\/p\/g2Vc38nLnR\" target=\"_blank\" rel=\"noopener\">https:\/\/line.me\/ti\/p\/g2Vc38nLnR<\/a><\/p>\n<p>#FDA\u5408\u898f #\u8de8\u5883\u96fb\u5546 #\u53f0\u7063\u8ce3\u5bb6 #483\u8868\u683c #\u8b66\u544a\u4fe1 #\u8de8\u5883\u51fa\u53e3\u5546 #\u4e9e\u99ac\u905c\u5168\u7403\u958b\u5e97 #\u54c1\u724c\u4fdd\u8b77 #\u570b\u969b\u96fb\u5546 #\u5168\u7403\u92b7\u552e<\/p>","protected":false},"excerpt":{"rendered":"<p>FDA\u6aa2\u67e5\u4e09\u5927\u6587\u4ef6\u5927\u89e3\u6790\uff1a483\u8868\u683c\u3001EIR\u8207\u8b66\u544a\u4fe1\u7684\u95dc\u9375\u5dee\u7570 \u4e09\u53e5\u8a71\u5fb9\u5e95\u89e3\u6c7aFDA\u6aa2\u67e5\u6587\u4ef6\u7591\u60d1\uff01\u5c0d\u65bc\u8a08\u5283\u9032\u8ecd [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[45],"tags":[],"class_list":["post-17001","post","type-post","status-publish","format-standard","hentry","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/17001"}],"collection":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/comments?post=17001"}],"version-history":[{"count":1,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/17001\/revisions"}],"predecessor-version":[{"id":17002,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/17001\/revisions\/17002"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=17001"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=17001"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=17001"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}