{"id":34861,"date":"2018-09-16T01:00:00","date_gmt":"2018-09-17T05:47:20","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/fda%ef%bc%9a%e7%bc%ac%e6%b2%99%e5%9d%a6%e5%86%8d%e7%88%86%e6%96%b0%e7%9a%84%e5%8f%af%e7%96%91%e8%87%b4%e7%99%8c%e7%89%a9%ef%bc%81\/"},"modified":"2018-09-17T13:47:21","modified_gmt":"2018-09-17T05:47:21","slug":"fda%ef%bc%9a%e7%bc%ac%e6%b2%99%e5%9d%a6%e5%86%8d%e7%88%86%e6%96%b0%e7%9a%84%e5%8f%af%e7%96%91%e8%87%b4%e7%99%8c%e7%89%a9%ef%bc%81","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/34861\/","title":{"rendered":"FDA\uff1a\u7f2c\u6c99\u5766\u518d\u7206\u65b0\u7684\u53ef\u7591\u81f4\u764c\u7269\uff01"},"content":{"rendered":"
\n

\u884c\u4e1a\u6700\u65b0\u653f\u7b56\u8d44\u8baf\uff1a\u5173\u6ce8\u201c<\/span><\/span><\/span><\/strong>\u201d<\/span><\/p>\n


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

FDA\u6700\u65b0\u7f2c\u6c99\u5766\u4ea7\u54c1\u7684\u8c03\u67e5\u7ed3\u679c\uff0c\u5e76\u5728\u53ec\u56de\u4ea7\u54c1\u4e2d\u53d1\u73b0\u65b0\u7684\u57fa\u56e0\u6bd2\u6027\u6742\u8d28<\/span><\/span><\/strong><\/p>\n

\"FDA\uff1a\u7f2c\u6c99\u5766\u518d\u7206\u65b0\u7684\u53ef\u7591\u81f4\u764c\u7269\uff01\" <\/span><\/p>\n

\u7f8e\u56fd<\/span>FDA\u66f4\u65b0\u4e86\u8fd1\u671f\u5173\u4e8e\u81ea\u613f\u53ec\u56de\u7684\u51e0\u79cd\u542b\u6709\u6d3b\u6027\u836f\u7269\u6210\u5206\uff08<\/span>API\uff09\u7f2c\u6c99\u5766\uff08\u7528\u4e8e\u6cbb\u7597\u9ad8\u8840\u538b\u548c\u5fc3\u529b\u8870\u7aed\uff09\u836f\u7269\u7684\u8c03\u67e5\u7ed3\u679c\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

FDA\u6700\u65b0\u7684\u4ea7\u54c1\u6d4b\u8bd5\u7ed3\u679c\u8868\u660e\uff0c\u4e09\u6279<\/span>Torrent\u5236\u836f\u516c\u53f8\u53ec\u56de\u7684\u7f2c\u6c99\u5766\u836f\u7269\u4ea7\u54c1\u4e2d\u5b58\u5728\u4e00\u79cd\u672a\u66fe\u9884\u6599\u7684\u6742\u8d28\u3002\u8be5\u6742\u8d28<\/span>N-\u4e9a\u785d\u57fa\u4e8c\u4e59\u80fa\uff08<\/span>NDEA\uff09\u662f\u5df2\u77e5\u7684\u52a8\u7269\u81f4\u764c\u7269\u8d28\u548c\u53ef\u7591\u7684\u4eba\u7c7b\u81f4\u764c\u7269\u8d28\u3002\u8fd9\u4e9b<\/span>Torrent\u4ea7\u54c1\u5728<\/span>2018\u5e74<\/span>8\u6708<\/span>23\u65e5\u53ec\u56de\u4ea7\u54c1\u5185\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

FDA\u548c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\u4e86\u89e3\u5230\uff0c\u6d59\u6c5f\u534e\u6d77\u836f\u4e1a\uff08<\/span>ZHP\uff09\u5728\u51e0\u6279\u7f2c\u6c99\u5766<\/span>API\u4e2d\u53d1\u73b0\u4e86<\/span>NDEA\u3002<\/span> FDA\u7acb\u5373\u5f00\u59cb\u91cd\u65b0\u68c0\u6d4b\u6240\u6709\u7f2c\u6c99\u5766<\/span>API\u548c\u5236\u5242\u4e2d\u7684<\/span>NDEA\uff0c\u5305\u62ec\u53ec\u56de\u7684\u4ea7\u54c1\u548c\u76ee\u524d\u5728\u7f8e\u56fd\u9500\u552e\u7684\u4ea7\u54c1\u3002\u6839\u636e\u5df2\u6709\u7684<\/span>FDA\u6d4b\u8bd5\u7ed3\u679c\uff0c\u8be5\u673a\u6784\u5728\u534e\u6d77\u836f\u4e1a\u7684\u4e00\u4e9b\u7f2c\u6c99\u5766<\/span>API\u4e2d\u53d1\u73b0\u4e86<\/span>NDEA\u3002\u5728<\/span>Torrent\u7684\u7f2c\u6c99\u5766<\/span>160mg\uff08\u6279\u6b21<\/span>BV47D001\uff09\u548c<\/span>320mg\uff08\u6279\u6b21<\/span>BV48D001\u548c<\/span>BV48D002\uff09\u7247\u5242\u4e2d\u4e5f\u53d1\u73b0\u4e86\u8be5\u6742\u8d28\uff0c\u8fd9\u4e9b\u7247\u5242\u662f\u4f7f\u7528\u6765\u81ea\u534e\u6d77\u836f\u4e1a\u7684<\/span>API\u5236\u5907\u7684\uff0c\u5e76\u4e14\u662f\u4e4b\u524d\u53ec\u56de\u7684\u4e00\u90e8\u5206\u3002<\/span> FDA\u7684\u6d4b\u8bd5\u8868\u660e\uff0c\u5e76\u975e\u6240\u6709\u4f7f\u7528\u534e\u6d77\u836f\u4e1a\u7684\u7f2c\u6c99\u5766<\/span>API\u5236\u9020\u7684\u5236\u5242\u90fd\u542b\u6709<\/span>NDEA\u6742\u8d28\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

 \u201c\u968f\u7740\u6211\u4eec\u7ee7\u7eed\u63a2\u7a76\u7f2c\u6c99\u5766\u5236\u5242\u4e2d\u8be5\u6742\u8d28\u4ea7\u751f\u7684\u6839\u6e90\uff0c\u6211\u4eec\u7684\u79d1\u5b66\u5bb6\u6b63\u5728\u68c0\u6d4b\u8fd9\u4e9b\u4ea7\u54c1\uff0c\u4ee5\u66f4\u597d\u5730\u4e86\u89e3\u8fd9\u4e9b\u6742\u8d28\uff0c\u5e76\u786e\u4fdd\u5b83\u4eec\u4e0d\u5b58\u5728\u4e8e\u5176\u4ed6\u4ea7\u54c1\u4e2d\u3002\u6211\u4eec\u8fd8\u91c7\u53d6\u63aa\u65bd\u786e\u4fdd\u6211\u4eec\u5bf9\u5236\u9020\u5de5\u827a\u8fdb\u884c\u4e25\u683c\u76d1\u7763\uff0c\u4ee5\u51cf\u5c11\u6742\u8d28\u88ab\u5f15\u5165\u5176\u4ed6\u4ea7\u54c1\u7684\u53ef\u80fd\u6027\uff0c\u201c<\/span>FDA\u5b98\u5458<\/span>Scott Gottlieb\uff0c<\/span>MD\u8bf4\u9053\u3002\u201d\u968f\u7740\u6211\u4eec\u6269\u5927\u7814\u7a76\u5de5\u4f5c\uff0c\u6211\u4eec\u5c06\u4f1a\u7ee7\u7eed\u786e\u4fdd\u516c\u4f17\u83b7\u5f97\u6700\u65b0\u4fe1\u606f\u3002\u6211\u4eec\u8fd8\u5c06\u7ee7\u7eed\u4e0e\u5168\u7403\u76d1\u7ba1\u673a\u6784\u5408\u4f5c\uff0c\u5c3d\u53ef\u80fd\u591a\u5730\u4e86\u89e3\u8fd9\u4e9b\u6742\u8d28\u662f\u5982\u4f55\u4ea7\u751f\u7684\uff0c\u4ee5\u53ca\u5b83\u4eec\u5982\u4f55\u5f71\u54cd\u5168\u7403\u60a3\u8005\u7684\u5065\u5eb7\u72b6\u51b5\u3002\u201d<\/span><\/span><\/p>\n

 <\/span><\/p>\n

FDA\u6b63\u5728\u7ee7\u7eed\u68c0\u6d4b\u6240\u6709\u7f2c\u6c99\u5766\u4ea7\u54c1\u4e2d\u7684<\/span>NDEA\u548c\u6709\u5173\u7269\u8d28\u3002\u5982\u679c\u8be5\u673a\u6784\u5728\u672a\u88ab\u53ec\u56de\u7684\u4ea7\u54c1\u4e2d\u53d1\u73b0<\/span>NDEA\uff0c<\/span>FDA\u5c06\u4e0e\u516c\u53f8\u5408\u4f5c\uff0c\u786e\u4fdd\u6240\u6709\u53d7\u5f71\u54cd\u7684\u4ea7\u54c1\u4ece\u5e02\u573a\u4e0a\u64a4\u56de\u3002\u8be5\u673a\u6784\u8fd8\u5728\u8bc4\u4f30\u8fd9\u4e9b\u4ea7\u54c1\u4e2d<\/span>NDEA\u5bf9\u60a3\u8005\u7684\u98ce\u9669\u3002<\/span> FDA\u5e0c\u671b\u5728\u672a\u6765\u51e0\u5929\u5b8c\u6210\u6b64\u98ce\u9669\u5206\u6790\uff0c\u5e76\u5c06\u5728\u65b0\u4fe1\u606f\u516c\u5e03\u540e\u7ee7\u7eed\u5411\u516c\u4f17\u63d0\u4f9b\u66f4\u65b0\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u4e0e\u5728\u53ec\u56de\u7684\u7f2c\u6c99\u5766\u4ea7\u54c1\u4e2d\u53d1\u73b0\u7684<\/span>N-\u4e9a\u785d\u57fa\u4e8c\u7532\u80fa\uff08<\/span>NDMA\uff09\u4e00\u6837\uff0c<\/span>NDEA\u4e5f\u7531\u7279\u5b9a\u7684\u751f\u4ea7\u5de5\u827a\u6b65\u9aa4\u548c\u5316\u5b66\u53cd\u5e94\u5f62\u6210\u3002\u9664\u4e86<\/span>FDA\u7684\u6d4b\u8bd5\u5916\uff0c\u8be5\u673a\u6784\u8fd8\u5c06\u53d1\u5e03\u68c0\u6d4b<\/span>NDEA\u7684\u521d\u6b65\u65b9\u6cd5\u3002\u5236\u9020\u5546\u548c\u5168\u7403\u836f\u76d1\u90e8\u95e8\u53ef\u4ee5\u4f7f\u7528\u8fd9\u79cd\u65b9\u6cd5\u7b5b\u9009\u5176\u4ed6\u4ea7\u54c1\u662f\u5426\u5b58\u5728\u8fd9\u79cd\u6742\u8d28\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u6b64\u5916\uff0c\u5982\u679c\u4ea7\u54c1\u68c0\u6d4b\u8fc7<\/span>NDEA\u5e76\u4e14\u6709\u66f4\u591a\u4fe1\u606f\u53ef\u4f9b\u4f7f\u7528\uff0c\u8be5\u673a\u6784\u5c06\u66f4\u65b0\u53ec\u56de\u4e2d\u5305\u542b\u7684\u4ea7\u54c1\u5217\u8868\u548c\u672a\u5305\u542b\u5728\u53ec\u56de\u4e2d\u7684\u4ea7\u54c1\u5217\u8868\u3002\u5982\u679c\u60a8\u6b63\u5728\u670d\u7528\u7f2c\u6c99\u5766\u4ea7\u54c1\uff0c\u8bf7\u52a1\u5fc5\u68c0\u67e5\u6e05\u5355\uff0c\u56e0\u4e3a\u5b83\u4eec\u53ef\u80fd\u4f1a\u53d1\u751f\u53d8\u5316\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u7f8e\u56fd<\/span>FDA\u5efa\u8bae\u670d\u7528\u53ec\u56de\u6279\u6b21\u7684\u7f2c\u6c99\u5766\u7684\u60a3\u8005\u7ee7\u7eed\u670d\u7528\u76ee\u524d\u7684\u836f\u7269\uff0c\u76f4\u5230\u4ed6\u4eec\u7684\u533b\u751f\u6216\u836f\u5242\u5e08\u63d0\u4f9b\u66ff\u4ee3\u6216\u4e0d\u540c\u7684\u6cbb\u7597\u65b9\u6848\u3002\u4efb\u4f55\u5c1a\u672a\u4e0e\u836f\u5242\u5e08\u6216\u533b\u751f\u4ea4\u8c08\u7684\u670d\u7528\u53ec\u56de\u6279\u6b21\u7f2c\u6c99\u5766\u7684\u60a3\u8005\u5e94\u8be5\u53ca\u65f6\u8fd9\u6837\u505a\u3002\u6b64\u65f6\uff0c<\/span>FDA\u7684\u68c0\u6d4b\u652f\u6301\u4ee5\u4e0b\u7ed3\u8bba\uff1a\u5e76\u975e\u6240\u6709\u7f2c\u6c99\u5766\u4ea7\u54c1\u90fd\u542b\u6709<\/span>NDMA\u6216<\/span>NDEA\uff0c\u56e0\u6b64\u836f\u5242\u5e08\u53ef\u80fd\u80fd\u591f\u63d0\u4f9b\u4e0d\u53d7\u53ec\u56de\u5f71\u54cd\u7684\u7f2c\u6c99\u5766\u836f\u7269\uff0c\u6216\u8005\u533b\u751f\u53ef\u80fd\u4f1a\u5f00\u51fa\u6cbb\u7597\u76f8\u540c\u75c5\u75c7\u7684\u4e0d\u540c\u836f\u7269\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

FDA\u662f\u7f8e\u56fd\u536b\u751f\u4e0e\u516c\u4f17\u670d\u52a1\u90e8\u7684\u4e00\u4e2a\u673a\u6784\uff0c\u901a\u8fc7\u786e\u4fdd\u4eba\u7528\u548c\u517d\u836f\uff0c\u75ab\u82d7\u548c\u5176\u4ed6\u4eba\u7528\u751f\u7269\u5236\u54c1\u4ee5\u53ca\u533b\u7597\u5668\u68b0\u7684\u5b89\u5168\u6027\uff0c\u6709\u6548\u6027\u548c\u4fdd\u969c\u6027\u6765\u4fdd\u62a4\u516c\u4f17\u5065\u5eb7\u3002\u8be5\u673a\u6784\u8fd8\u8d1f\u8d23\u98df\u54c1\u4f9b\u5e94\uff0c\u5316\u5986\u54c1\uff0c\u81b3\u98df\u8865\u5145\u5242\uff0c\u7535\u5b50\u8f90\u5c04\u7684\u4ea7\u54c1\u4ee5\u53ca\u70df\u8349\u5236\u54c1\u7684\u5b89\u5168\u6027\u548c\u4fdd\u969c\u6027\u3002<\/span><\/span><\/p>\n

\n

\u539f\u6587\u94fe\u63a5\uff1a<\/span><\/p>\n

https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm620499.htm<\/span><\/p>\n


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

\u4ee5\u4e0b\u4e3a\u5546\u52a1\u63a8\u5e7f\uff0c\u4e0e\u6587\u7ae0\u65e0\u5173\u3002<\/span>\u67cf\u864e\u79d1\u6280\u52a9\u529b\u4e2d\u56fd\u5b9e\u9a8c\u5ba4\u5efa\u8bbe<\/span><\/strong>\uff0c\u6253\u9020\u4e00\u4f53\u5316\u5b9e\u9a8c\u5ba4\u5de5\u7a0b\u670d\u52a1\u5e73\u53f0\u3002\u8054\u7cfb\u4eba\uff1a\u4f55\u7ecf\u7406  <\/span><\/strong>13913118411<\/span><\/strong><\/span>\uff08\u5fae\u4fe1\u540c\u53f7\uff09<\/span><\/strong><\/p>\n

\n


<\/span>
<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u884c\u4e1a\u6700\u65b0\u653f\u7b56\u8d44\u8baf\uff1a\u5173\u6ce8\u201c\u201d FDA\u6700\u65b0\u7f2c\u6c99\u5766\u4ea7\u54c1\u7684\u8c03\u67e5\u7ed3\u679c\uff0c\u5e76\u5728\u53ec\u56de\u4ea7\u54c1\u4e2d\u53d1\u73b0\u65b0\u7684\u57fa\u56e0\u6bd2\u6027\u6742\u8d28   […]<\/p>\n","protected":false},"author":1,"featured_media":34862,"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\/34861"}],"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=34861"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/34861\/revisions"}],"predecessor-version":[{"id":34864,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/34861\/revisions\/34864"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/34862"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=34861"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=34861"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=34861"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}