{"id":57022,"date":"2018-09-26T01:00:00","date_gmt":"2018-09-30T02:22:03","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/fda-%e5%8f%91%e5%b8%83%e4%b8%a4%e4%bb%bd%e6%8c%87%e5%8d%97%e4%b8%ba%e8%8d%af%e5%93%81%e7%94%b3%e8%af%b7%e7%9a%84%e9%ab%98%e8%b4%a8%e9%87%8f%e9%80%92%e4%ba%a4%e6%8f%90%e4%be%9b%e5%bb%ba%e8%ae%ae\/"},"modified":"2018-09-30T10:22:04","modified_gmt":"2018-09-30T02:22:04","slug":"fda-%e5%8f%91%e5%b8%83%e4%b8%a4%e4%bb%bd%e6%8c%87%e5%8d%97%e4%b8%ba%e8%8d%af%e5%93%81%e7%94%b3%e8%af%b7%e7%9a%84%e9%ab%98%e8%b4%a8%e9%87%8f%e9%80%92%e4%ba%a4%e6%8f%90%e4%be%9b%e5%bb%ba%e8%ae%ae","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/57022\/","title":{"rendered":"FDA \u53d1\u5e03\u4e24\u4efd\u6307\u5357\u4e3a\u836f\u54c1\u7533\u8bf7\u7684\u9ad8\u8d28\u91cf\u9012\u4ea4\u63d0\u4f9b\u5efa\u8bae"},"content":{"rendered":"
\n

\u7f8e\u56fd FDA \u4e8e 9 \u6708 24 \u65e5\u53d1\u5e03\u4e86\u300aANDA \u9012\u4ea4 \u2014 \u5185\u5bb9\u548c\u683c\u5f0f\u300b\u5b9a\u7a3f\u6307\u5357\u3002\u8fd9\u4efd\u957f\u8fbe 32 \u9875\u7684\u6307\u5357\u6bd4 2014 \u5e74\u7684\u6307\u5357\u8349\u6848\u66f4\u8be6\u7ec6\uff0c\u63d0\u4f9b\u4e86\u5bf9\u6587\u4ef6\u67d0\u4e9b\u90e8\u5206\u548c\u8981\u6c42\u7684\u6269\u5c55\u8bf4\u660e\u3002\u540c\u65f6\u8fd8\u53d1\u5e03\u4e86\u300aNDA \u548c BLA \u826f\u597d\u5ba1\u8bc4\u7ba1\u7406\u539f\u5219\u548c\u5b9e\u8df5\u300b\u6307\u5357\u8349\u6848\uff0c\u5411\u5de5\u4e1a\u754c\u548c\u5ba1\u8bc4\u5de5\u4f5c\u4eba\u5458\u4ecb\u7ecd\u4e86\u5728\u65b0\u836f\u5ba1\u8bc4\u4e2d\u5ba1\u8bc4\u4eba\u5458\u7684\u804c\u8d23\u4ee5\u53ca\u826f\u597d\u5ba1\u8bc4\u7ba1\u7406\u539f\u5219\u548c\u5b9e\u8df5\uff08GRMP\uff09\u3002<\/span><\/p>\n

\u8fd9\u4e24\u4efd\u6307\u5357\u7684\u53d1\u5e03\u662f FDA \u836f\u54c1\u7ade\u4e89\u884c\u52a8\u8ba1\u5212\u7684\u4e00\u90e8\u5206\uff0cFDA \u5c40\u957f Scott Gottlieb \u8868\u793a\uff0c\u201c\u4f5c\u4e3a\u6211\u4eec\u4e0d\u65ad\u52aa\u529b\u964d\u4f4e\u836f\u4ef7\u548c\u6539\u5584\u521b\u65b0\u836f\u53ef\u53ca\u6027\u5de5\u4f5c\u7684\u4e00\u90e8\u5206\uff0cFDA \u53d1\u5e03\u4e24\u4efd\u6307\u5357\u6587\u4ef6\u534f\u52a9 FDA \u5de5\u4f5c\u4eba\u5458\u548c\u884c\u4e1a\uff0c\u786e\u4fdd\u65b0\u836f\u5ba1\u8bc4\u7a0b\u5e8f\u548c\u4eff\u5236\u836f\u5ba1\u8bc4\u7a0b\u5e8f\u7ba1\u7406\u7684\u4e00\u81f4\u3001\u900f\u660e\u548c\u9ad8\u6548\u3002\u201d<\/span><\/p>\n

ANDA \u9012\u4ea4\u5185\u5bb9\u548c\u683c\u5f0f\u5b9a\u7a3f\u6307\u5357<\/strong><\/span><\/p><\/blockquote>\n

ANDA \u9012\u4ea4\u5b9a\u7a3f\u6307\u5357\u65e8\u5728\u5e2e\u52a9\u7533\u8bf7\u4eba\u51c6\u5907\u5b8c\u6574\u7684\u3001\u53ef\u9012\u4ea4\u7684 ANDA \u7533\u8bf7\u3002\u5b9a\u7a3f\u6307\u5357\u8be6\u7ec6\u8bf4\u660e\u4e86\u4eba\u7528\u836f\u7533\u8bf7\u901a\u7528\u6280\u672f\u6587\u4ef6\uff08CTD\uff09\u683c\u5f0f\u4e2d\u6bcf\u90e8\u5206\u7684\u4fe1\u606f\uff0c\u5e76\u7ed9\u51fa\u4e86 FDA \u53d1\u5e03\u7684\u652f\u6301\u6027\u6307\u5357\u6587\u4ef6\u548c\u5efa\u8bae\uff0c\u4ee5\u5e2e\u52a9\u7533\u8bf7\u4eba\u51c6\u5907\u5176 ANDA \u9012\u4ea4\u3002\u5728\u8003\u8651\u4e86\u5bf9 2014 \u5e74\u6307\u5357\u8349\u6848\u7248\u672c\u7684\u516c\u4f17\u53cd\u9988\u610f\u89c1\u4e4b\u540e\uff0cFDA \u5728\u5b9a\u7a3f\u6307\u5357\u4e2d\u505a\u4e86\u6280\u672f\u6f84\u6e05\u5e76\u66f4\u65b0\u4e86\u53c2\u8003\u6587\u4ef6\u3002\u4ece\u5386\u53f2\u4e0a\u770b\uff0c\u9700\u8981\u4e00\u4ef6 ANDA \u9700\u8981\u56db\u8f6e\u5ba1\u8bc4\u5468\u671f\u624d\u80fd\u83b7\u5f97\u6279\u51c6\uff0c\u8be5\u5b9a\u7a3f\u6307\u5357\u201c\u901a\u8fc7\u5411\u884c\u4e1a\u6f84\u6e05\u5982\u4f55\u4ece\u4e00\u5f00\u59cb\u5c31\u63d0\u4ea4\u5b8c\u6574\u3001\u9ad8\u8d28\u91cf\u7684\u7533\u8bf7\u6765\u51cf\u5c11\u5ba1\u8bc4\u8f6e\u6b21\u201d\u3002<\/span><\/p>\n

\u6307\u5357\u5bf9 eCTD \u7684\u6bcf\u90e8\u5206\u90fd\u6709\u5efa\u8bae\uff0c\u503c\u5f97\u82b1\u65f6\u95f4\u4ed4\u7ec6\u9605\u8bfb\u8be5\u6307\u5357\uff0c\u5e76\u6ce8\u610f\u4e0e\u6307\u5357\u8349\u6848\u76f8\u6bd4\u7684\u53d8\u5316 , \u4ee5\u5e2e\u52a9\u4f01\u4e1a\u66f4\u597d\u5730\u7ec4\u7ec7\u53ef\u4ee5\u5728\u201c\u9996\u8f6e\u201d\u83b7\u6279\u7684 ANDA\u3002\u8bc6\u6797\u5c06\u4e8e\u8fd1\u671f\u63a8\u51fa\u8be5\u5b9a\u7a3f\u6307\u5357\u4e0e\u5386\u53f2\u7248\u672c\u7684\u5bf9\u6bd4\u89e3\u8bfb\u53ca\u7ffb\u8bd1\u7a3f\u3002<\/span><\/span><\/p>\n

NDA \u548c BLA \u826f\u597d\u5ba1\u8bc4\u7ba1\u7406\u539f\u5219\u548c\u5b9e\u8df5\u6307\u5357\u8349\u6848<\/strong><\/span><\/p><\/blockquote>\n

\u8fd9\u4efd 8 \u9875\u7684\u6307\u5357\u8349\u6848\u8ba8\u8bba\u4e86 FDA \u5ba1\u8bc4\u4eba\u5458\u5728\u7ba1\u7406\u5ba1\u8bc4\u7a0b\u5e8f\u5de5\u4f5c\u4e2d\u7684\u804c\u8d23\uff0c\u5e76\u6307\u51fa\u7533\u8bf7\u4eba\u5982\u4f55\u901a\u8fc7\u826f\u597d\u5ba1\u8bc4\u7ba1\u7406\u539f\u5219\u548c\u5b9e\u8df5\uff08GRMP\uff09\u652f\u6301\u9ad8\u6548\u7684\u65b0\u836f\u6216\u751f\u7269\u5236\u54c1\u7533\u8bf7\u5ba1\u8bc4\u7a0b\u5e8f\u3002\u6307\u5357\u8349\u6848\u8868\u793a\uff0c\u201cGRMP \u7684\u76ee\u6807\u662f\u786e\u4fdd\u4ee5\u4e00\u81f4\u548c\u9ad8\u6548\u7684\u65b9\u5f0f\u7ba1\u7406\u5ba1\u8bc4\u7a0b\u5e8f , \u4ece\u800c\u51cf\u5c11\u6279\u51c6\u6240\u9700\u7684\u5ba1\u8bc4\u5468\u671f\u6570\uff0c\u5e76\u63d0\u9ad8\u60a3\u8005\u5bf9\u91cd\u8981\u6cbb\u7597\u836f\u7684\u53ca\u65f6\u83b7\u53d6\u3002\u201d\u6307\u5357\u8349\u6848\u5305\u542b\u57fa\u672c\u4ef7\u503c\uff08\u5305\u62ec\u95ee\u8d23\u5236\u3001\u6c9f\u901a\u548c\u4e00\u81f4\u6027\uff09 , \u8fd0\u8425\u539f\u5219\uff08\u53ca\u65f6\u9891\u7e41\u7684\u5ba1\u8bc4\u56e2\u961f\u534f\u4f5c\u5bf9\u4e8e\u826f\u597d\u5ba1\u8bc4\u7ba1\u7406\u81f3\u5173\u91cd\u8981\uff09\u4ee5\u53ca\u66f4\u591a\u5173\u4e8e\u65b0\u4ea7\u54c1\u5ba1\u8bc4\u7a0b\u5e8f\u7684\u5185\u5bb9\u3002<\/span><\/p>\n

\u8be5\u6307\u5357\u8349\u6848\u4fee\u8ba2\u4e86 2005 \u5e74 4 \u6708\u53d1\u5e03\u7684\u9898\u4e3a\u300aPDUFA \u4ea7\u54c1\u826f\u597d\u5ba1\u8bc4\u7ba1\u7406\u539f\u5219\u548c\u5b9e\u8df5\u300b\u7684\u5ba1\u8bc4\u4eba\u5458\u548c\u884c\u4e1a\u6307\u5357\uff0c\u8fd9\u4e00\u4fee\u8ba2\u5de5\u4f5c\u662f FDA \u4f5c\u4e3a\u5904\u65b9\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u6cd5\u6848\uff08PDUFA\uff09VI \u548c\u751f\u7269\u7c7b\u4f3c\u836f\u4f7f\u7528\u8005\u4ed8\u8d39\u6cd5\u6848\uff08BsUFA\uff09II \u7684\u4e00\u90e8\u5206\u627f\u8bfa\u8fdb\u884c\u7684\u6307\u5357\u66f4\u65b0\u3002<\/span><\/p>\n

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

\n

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

Final ANDA Submission Guidance Published Today – Lachman Consultants<\/span><\/p>\n

Drug Competition Action Plan: FDA Issues One Draft, One Final Guidance – 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>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u7f8e\u56fd FDA \u4e8e 9 \u6708 24 \u65e5\u53d1\u5e03\u4e86\u300aANDA \u9012\u4ea4 \u2014 \u5185\u5bb9\u548c\u683c\u5f0f\u300b\u5b9a\u7a3f\u6307\u5357\u3002\u8fd9\u4efd\u957f\u8fbe 32 \u9875\u7684\u6307\u5357\u6bd4 […]<\/p>\n","protected":false},"author":1,"featured_media":57023,"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\/57022"}],"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=57022"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57022\/revisions"}],"predecessor-version":[{"id":57026,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/57022\/revisions\/57026"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/57023"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=57022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=57022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=57022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}