{"id":57010,"date":"2018-09-28T01:00:00","date_gmt":"2018-09-30T02:21:55","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/fda-%e4%bb%8a%e5%b9%b4%e7%ad%be%e5%8f%91%e6%9b%b4%e5%a4%9a%e5%ae%8c%e5%85%a8%e5%9b%9e%e5%ba%94%e5%87%bd\/"},"modified":"2018-09-30T10:21:55","modified_gmt":"2018-09-30T02:21:55","slug":"fda-%e4%bb%8a%e5%b9%b4%e7%ad%be%e5%8f%91%e6%9b%b4%e5%a4%9a%e5%ae%8c%e5%85%a8%e5%9b%9e%e5%ba%94%e5%87%bd","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/57010\/","title":{"rendered":"FDA \u4eca\u5e74\u7b7e\u53d1\u66f4\u591a\u5b8c\u5168\u56de\u5e94\u51fd"},"content":{"rendered":"
\n

2018 \u8d22\u5e74\u7f8e\u56fd FDA \u5bf9\u7b80\u5316\u65b0\u836f\u7533\u8bf7\uff08ANDA\uff09\u7b7e\u53d1\u4e86\u8fdc\u8d85\u8fc7\u4ee5\u5f80\u4efb\u4f55\u5e74\u4efd\u7684\u5b8c\u5168\u56de\u5e94\u51fd\uff08CRL\uff09\u3002<\/span>2018 \u8d22\u5e74\u5230\u76ee\u524d\u4e3a\u6b62\u7b7e\u53d1 2515 \u5c01 CRL\uff0c2017 \u8d22\u5e74\u4e3a 1603 \u5c01\uff0c2016 \u8d22\u5e74\u4e3a 1725 \u5c01\u3002<\/span>RAPS \u7684\u64b0\u7a3f\u4eba Zachary Brennan \u8868\u793a\uff0c\u8fd9\u53ef\u80fd\u662f\u7531\u4e8e\u7533\u8bf7\u6570\u91cf\u6fc0\u589e\u6216\u5176\u5b83\u539f\u56e0\u9020\u6210\u7684\u3002<\/span><\/p>\n

\u4f46\u524d\u51e0\u5e74\u7684\u7533\u8bf7\u63d0\u4ea4\u91cf\u80af\u5b9a\u66f4\u9ad8\uff0c\u5373\u4f7f 2018 \u8d22\u5e74\u7684 ANDA \u63d0\u4ea4\u6709\u53ef\u80fd\u4e5f\u8d85\u8fc7 1000 \u4ef6\u3002\u4f8b\u5982\uff0c2017 \u8d22\u5e74\u4eff\u5236\u836f\u529e\u516c\u5ba4\uff08OGD\uff09\u6536\u5230 1306 \u4ef6 ANDA\uff0c2014 \u8d22\u5e74\u6536\u5230 1473 \u4ef6\u3002\u4f46\u5728 2014 \u8d22\u5e74\u7533\u8bf7\u63d0\u4ea4\u6fc0\u589e\u4e4b\u540e\uff0cOGD \u4e5f\u4ec5\u7b7e\u53d1\u4e86 1180 \u4efd CRL\u3002\u4e3a\u4ec0\u4e48\u6709\u90a3\u4e48\u5927\u7684\u5dee\u8ddd\u5462\uff1f<\/span><\/p>\n

\u666e\u4eab\u836f\u534f\u4f1a\uff08AAM\uff09\u79d1\u5b66\u548c\u76d1\u7ba1\u4e8b\u52a1\u9ad8\u7ea7\u526f\u603b\u88c1 David Gaugh \u8868\u793a\uff0c\u201cGDUFA II \u7684\u7b2c\u4e00\u5e74\uff0c\u5b8c\u5168\u56de\u5e94\u51fd\u7684\u6570\u91cf\u4e0e\u65b0\u76ee\u6807\u548c\u6307\u6807\u8c08\u5224\u65f6\u7684\u9884\u671f\u4e00\u81f4\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u4f5c\u4e3a\u5411 GDUFA II \u8fc1\u79fb\u7684\u4e00\u90e8\u5206\uff0c\u6709\u4e00\u4e2a\u8854\u63a5\u8fc7\u7a0b\uff0c\u5bf9\u4e8e\u5728 GDUFA I \u4e2d\u6ca1\u6709\u6b63\u5f0f\u76ee\u6807\u65e5\u671f\u7684\u7ea6 800 \u4ef6\u7533\u8bf7\u786e\u7acb\u4e86 2018 \u5e74 7 \u670831 \u65e5\u7684\u76ee\u6807\u65e5\u671f\uff0c\u8fd9\u5f88\u53ef\u80fd\u662f\u8fd9\u6bb5\u65f6\u95f4\u5185\u6574\u4f53\u7533\u8bf7\u6fc0\u589e\u7684\u539f\u56e0\u3002\u201d<\/span><\/p>\n

\u800c\u4e1a\u754c\u8d44\u6df1\u4eba\u58eb Bob Pollock \u8ba4\u4e3a\u8fd9\u53ef\u80fd\u53ea\u662f\u95ee\u9898\u7684\u4e00\u90e8\u5206\uff0c\u201cDavid \u5bf9 FDA \u548c\u884c\u4e1a\u6574\u4f53\u90fd\u6bd4\u8f83\u53cb\u597d\u201d\u3002Pollock \u8ba4\u4e3a FDA \u5de5\u4f5c\u4eba\u5458\u7684\u589e\u52a0\u4ee5\u53ca\u836f\u54c1\u8d28\u91cf\u529e\u516c\u5ba4\uff08OPQ\uff09\u7684\u6210\u7acb\u90fd\u4f7f\u5f97 CRL \u7b7e\u53d1\u589e\u52a0\uff0c\u4f46\u8fd8\u6709\u5176\u5b83\u539f\u56e0\uff1a<\/span><\/p>\n

\u2022\tOGD \u975e\u5e38\u91cd\u89c6 GDUFA \u76ee\u6807\uff0c\u867d\u7136\u4ed6\u4eec\u66fe\u8868\u793a\u8fc7\uff0c\u5982\u679c\u9519\u8fc7\u76ee\u6807\u65e5\u671f\u53ef\u80fd\u610f\u5473\u7740\u7533\u8bf7\u5373\u5c06\u83b7\u6279\uff0c\u90a3\u4e48\u4ed6\u4eec\u53ef\u80fd\u4f1a\u9519\u8fc7\u76ee\u6807\u65e5\u671f\u3002\u6211\u4eec\u5e76\u4e0d\u786e\u5b9a\u4ed6\u4eec\u662f\u5426\u4f1a\u59cb\u7ec8\u5982\u4e00\u7684\u8fd9\u4e48\u505a\uff0c\u4f46\u4e8b\u5b9e\u4e0a\uff0c\u6709\u6570\u636e\u8868\u660e\u4ed6\u4eec\u73b0\u5728\u66f4\u613f\u610f\u9519\u8fc7\u76ee\u6807\u65e5\u671f\u3002<\/span><\/p>\n

\u2022\t\u5176\u6b21\uff0c\u5728 ANDA \u5ba1\u8bc4\u671f\u95f4\uff0c\u4fe1\u606f\u8bf7\u6c42\uff08IR\uff09\u548c\u5b66\u79d1\u5ba1\u8bc4\u51fd\uff08DRL\uff09\u7684\u6570\u91cf\u4e5f\u5728\u6fc0\u589e\u3002<\/span>\u5f88\u591a\u65f6\u5019\uff0cIR \u548c DRL \u7684\u6570\u91cf\u538b\u57ae\u4e86\u7533\u529e\u4eba\uff0c\u4ed6\u4eec\u65e0\u6cd5\u5728\u89c4\u5b9a\u7684\u65f6\u95f4\u5185\u7ed9\u51fa\u56de\u590d<\/span>\uff0c\u4e0d\u5f97\u4e0d\u6839\u636e\u4ea7\u54c1\u5bf9\u5176\u5e95\u7ebf\u7684\u91cd\u8981\u6027\uff0c\u4e0d\u65ad\u4f18\u5148\u8003\u8651\u4ed6\u4eec\u5e94\u9996\u5148\u56de\u590d\u54ea\u4e9b\u4fe1\u51fd\u3002\u8fd9\u79cd\u5bf9\u5176\u5b83\u4e0d\u751a\u91cd\u8981\u7684 IR \u548c DRL \u56de\u590d\u7684\u5ef6\u8fdf\u53ef\u80fd\u5bfc\u81f4 OGD \u53d1\u5e03 CRL\u3002\u8bf7\u8bb0\u4f4f\uff0cIR \u548c DRL \u4ec5\u9002\u7528\u4e8e GDUFA II \u7533\u8bf7\uff0c\u800c GDUFA I \u7533\u8bf7\uff0c\u867d\u7136\u73b0\u5728\u4e5f\u5177\u6709 GDUFA \u76ee\u6807\u65e5\u671f\uff0c\u4f46\u4e0d\u80fd\u83b7\u76ca\u4e8e\u4e2d\u671f\u5ba1\u8bc4\u53cd\u9988\u3002\u8fd9\u53ef\u80fd\u4f1a\u4f7f\u5f97 CRL \u589e\u52a0\u3002<\/span><\/p>\n

\u2022\tOGD \u5e0c\u671b\u80fd\u6709\u66f4\u591a\u9996\u8f6e\u6279\u51c6\uff0c\u4f46\u4ee4\u4eba\u4e0d\u89e3\u7684\u662f\uff0c\u8bb8\u591a\u8457\u540d\u516c\u53f8\u7ee7\u7eed\u6536\u5230\u76f8\u5f53\u5197\u957f\u7684 CRL\u3002\u5728\u6700\u8fd1\u53ec\u5f00\u7684 GRx-Biosims \u666e\u4eab\u836f\u534f\u4f1a\u4f1a\u8bae\u4e0a\uff0cOGD \u4e3b\u4efb Kathleen Uhl \u8868\u793a\uff0c\u5bf9\u4e8e\u62d2\u6536\u884c\u52a8\uff0c\u201c\u653e\u6162\u811a\u6b65\uff0c\u5728\u63d0\u4ea4\/\u91cd\u65b0\u63d0\u4ea4\u4e4b\u524d QA\/QC \u6574\u4e2a ANDA\u201d\u3002\u8fd9\u662f\u4e00\u4e2a\u5f88\u597d\u7684\u5efa\u8bae\uff0c<\/span>\u4f46\u76f8\u540c\u7684\u8b66\u544a\u540c\u6837\u9002\u7528\u4e8e ANDA \u5ba1\u8bc4\u4eba\u5458\uff0c\u6216\u8bb8\u4ed6\u4eec\u4e5f\u9700\u8981\u653e\u6162\u901f\u5ea6\uff0cQA\/QC \u4ed6\u4eec\u7684\u5ba1\u8bc4\uff0c\u56e0\u4e3a\u6709\u4e9b\u95ee\u9898\u8981\u4e48\u4e0d\u9002\u7528\u4e8e\u4ea7\u54c1\uff0c\u8981\u4e48\u5728\u7533\u8bf7\u4e2d\u6709\u660e\u786e\u7684\u4fe1\u606f\u3002<\/span>\u6211\u8ba4\u4e3a\u53cc\u65b9\u90fd\u6709\u8d23\u4efb\u3002\u4e5f\u8bb8\u5f53 FDA \u5c06\u5ba1\u8bc4\u6d41\u7a0b\u53d8\u4e3a\u66f4\u52a0\u6570\u636e\u9a71\u52a8\u7684\uff0c\u800c\u4e0d\u662f\u53d9\u8ff0\u9a71\u52a8\u7684\u7533\u8bf7\u65f6\uff0c\u4f1a\u6709\u6240\u5e2e\u52a9\u3002<\/span>\u3010FDA \u77e5\u8bc6\u8f85\u52a9\u8bc4\u4f30\u548c\u7ed3\u6784\u5316\u7533\u8bf7\u8ba1\u5212\u63d0\u4e0a\u8bae\u7a0b\u3011<\/a><\/span><\/p>\n

Pollock \u8868\u793a\uff0c\u4ed6\u5e76\u4e0d\u662f\u8981\u62a8\u51fb FDA\uff0c\u884c\u4e1a\u4e5f\u5b58\u5728\u95ee\u9898\u3002\u201c\u6211\u5e0c\u671b\u6211\u77e5\u9053\u5982\u4f55\u89e3\u51b3\u8fd9\u4e2a\u95ee\u9898 , \u4f46\u6709\u4eba\u4f1a\u8ba4\u4e3a\uff0c\u9664\u975e\u516c\u53f8\u662f\u521a\u5165\u884c\u7684\u65b0\u624b\uff0c\u5426\u5219\u4ed6\u4eec\u53ef\u4ee5\u6b63\u4e2d\u8981\u5bb3\u5e76\u4e14\u9996\u6b21\u5373\u5bf9\u3002\u800c\u884c\u4e1a\u7ee7\u7eed\u62b1\u6028\u2018\u79fb\u52a8\u7684\u5ba1\u8bc4\u76ee\u6807\u2019\u8fd9\u4e00\u53e4\u8001\u95ee\u9898 , \u4ee5\u53ca\u5728\u5ba1\u8bc4\u671f\u95f4\u7ecf\u5e38\u63d0\u51fa\u5b8c\u5168\u4e0d\u540c\u7684\u95ee\u9898\u7684\u5ba1\u8bc4\u4eba\u5458\uff0c\u8fd9\u4e9b\u90fd\u4f7f\u4f01\u4e1a\u96be\u4ee5\u9996\u6b21\u5373\u5bf9\u3002\u8fd9\u770b\u8d77\u6765\u6709\u70b9\u50cf\u4f01\u4e1a\u4f3c\u4e4e\u4e0d\u80fd\u7ecf\u5e38\u53d6\u60a6\u5ba1\u8bc4\u4eba\u5458\u3002\u6216\u8bb8 GDUFA III \u5c06\u4f1a\u89e3\u51b3\u5176\u4e2d\u4e00\u4e9b\u95ee\u9898\u3002\u201d<\/span><\/p>\n

\u6574\u7406\uff1a\u8bc6\u6797-\u6912
<\/span><\/p>\n

\n

\u53c2\u8003\u8d44\u6599<\/strong><\/span><\/p>\n

More Complete Response Letters \u2013 Good News or Bad News? – Lachman Consultants<\/span><\/p>\n

Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance – FDA<\/span><\/p>\n

FDA Smashes Record for Most ANDA Complete Responses in one Year – RAPS<\/span><\/p>\n<\/blockquote>\n

\"FDA
<\/p>\n

\u3010\u5173\u4e8e\u8bc6\u6797 – \u5e38\u89c1\u95ee\u9898\u4e0e\u89e3\u7b54<\/span><\/strong><\/span>\u3011<\/span><\/strong><\/span><\/a>
<\/p>\n

\"FDA<\/p>\n

\u957f\u6309\u4e0b\u65b9\u4e8c\u7ef4\u7801\u4e0b\u8f7d<\/span><\/strong>\u8bc6\u6797<\/span>\u00ae<\/sup><\/span><\/strong><\/span>App<\/span><\/strong><\/span><\/p>\n

\n

\u8bc6\u6797<\/span>\u00ae<\/span><\/sup>\u7248\u6743\u6240\u6709\uff0c\u672a\u7ecf\u8bb8\u53ef\u4e0d\u5f97\u8f6c\u8f7d\u3002<\/span><\/span><\/strong><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

2018 \u8d22\u5e74\u7f8e\u56fd FDA \u5bf9\u7b80\u5316\u65b0\u836f\u7533\u8bf7\uff08ANDA\uff09\u7b7e\u53d1\u4e86\u8fdc\u8d85\u8fc7\u4ee5\u5f80\u4efb\u4f55\u5e74\u4efd\u7684\u5b8c\u5168\u56de\u5e94\u51fd\uff08CRL\uff09\u30022018 […]<\/p>\n","protected":false},"author":1,"featured_media":57011,"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\/57010"}],"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=57010"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57010\/revisions"}],"predecessor-version":[{"id":57014,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57010\/revisions\/57014"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/57011"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=57010"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=57010"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=57010"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}