{"id":7370,"date":"2017-11-25T14:09:29","date_gmt":"2017-11-25T19:09:29","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/fda-approval-process\/"},"modified":"2017-11-25T14:09:29","modified_gmt":"2017-11-25T19:09:29","slug":"fda-%e6%89%b9%e5%87%86%e7%a8%8b%e5%ba%8f","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/zh\/article\/fda-%e6%89%b9%e5%87%86%e7%a8%8b%e5%ba%8f\/","title":{"rendered":"\u4ec0\u4e48\u662f FDA \u6279\u51c6\u7a0b\u5e8f\uff1f"},"content":{"rendered":"<p>\u5904\u65b9\u836f\u5728\u7f8e\u56fd\u9500\u552e\u4e4b\u524d\uff0c\u5fc5\u987b\u7ecf\u8fc7\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u7ba1\u7406\u7684\u4e25\u683c\u5ba1\u6279\u7a0b\u5e8f\u3002 FDA \u6279\u51c6\u7a0b\u5e8f\u7684\u91cd\u70b9\u662f\u4ee5\u5404\u79cd\u65b9\u5f0f\u6d4b\u8bd5\u836f\u7269\u5e76\u786e\u5b9a\u5176\u529f\u6548\u53ca\u5176\u5e26\u6765\u7684\u4efb\u4f55\u98ce\u9669\u6216\u5371\u9669\u3002\u4e0d\u5e78\u7684\u662f\uff0c\u6279\u51c6\u7a0b\u5e8f\u2014\u2014\u867d\u7136\u5b83\u65e8\u5728\u4fdd\u62a4\u6d88\u8d39\u8005\u514d\u53d7\u5371\u9669\u836f\u7269\u7684\u4fb5\u5bb3\u2014\u2014\u5e76\u4e0d\u603b\u662f\u50cf\u5b83\u5e94\u8be5\u7684\u90a3\u6837\u5f7b\u5e95\uff0c\u800c\u4e14\u8bb8\u591a\u5371\u9669\u836f\u7269\u90fd\u662f\u7531 FDA \u6279\u51c6\u7684\u3002<\/p>\n<p>\u5feb\u901f\u6d4f\u89c8\u4e00\u4e0b <a href=\"https:\/\/napolilaw.lemonadestand.org\/zh\/%e7%bb%83%e4%b9%a0%e5%8c%ba\/%e5%8c%bb%e8%8d%af%e8%af%89%e8%ae%bc\/fda%e6%89%b9%e5%87%86\/\">FDA\u5ba1\u6279\u5236\u5ea6<\/a> \u5728\u836f\u7269\u5f00\u53d1\u3001\u52a8\u7269\u8bd5\u9a8c\u4ee5\u53ca\u5236\u9020\u5546\u63d0\u4ea4 IND\uff08\u7814\u7a76\u6027\u65b0\u836f\uff09\u7533\u8bf7\u540e\u8d77\u4f5c\u7528\uff1a<\/p>\n<h2>1\u30012 \u548c 3 \u671f\u836f\u7269\u6d4b\u8bd5<\/h2>\n<p>\u4e00\u65e6 FDA \u6536\u5230 IND\uff0c\u5b83\u5c06\u5bf9\u5176\u8fdb\u884c\u5ba1\u67e5\uff0c\u4ee5\u786e\u5b9a\u6d89\u53ca\u4eba\u7c7b\u5fd7\u613f\u8005\u7684\u62df\u8bae\u4e34\u5e8a\u7814\u7a76\u662f\u5426\u5408\u9002\uff0c\u4ee5\u53ca\u6b64\u7c7b\u7814\u7a76\u7684\u98ce\u9669\u662f\u4ec0\u4e48\u3002\u5982\u679c\u6279\u51c6\u7a0b\u5e8f\u53d6\u5f97\u8fdb\u5c55\uff0c\u836f\u7269\u6d4b\u8bd5\u5c06\u5206\u4e3a\u4e09\u4e2a\u9636\u6bb5\uff1a<\/p>\n<ul>\n<li><strong>\u9636\u6bb51 - <\/strong>\u7b2c\u4e00\u9636\u6bb5\u6d4b\u8bd5\u7740\u773c\u4e8e\u8be5\u836f\u7269\u5bf9 20 \u81f3 80 \u4eba\u7684\u4e00\u7ec4\u7684\u526f\u4f5c\u7528\uff1b<\/li>\n<li><strong>\u9636\u6bb52 - <\/strong>\u5047\u8bbe\u7b2c\u4e00\u9636\u6bb5\u6210\u529f\uff0c\u7b2c\u4e8c\u9636\u6bb5\u5c06\u5f00\u59cb\uff0c\u5c06\u5728\u6570\u767e\u4eba\u8eab\u4e0a\u6d4b\u8bd5\u836f\u7269\u7684\u6709\u6548\u6027\uff1b\u548c<\/li>\n<li><strong>\u7b2c 3 \u9636\u6bb5 \u2013 <\/strong>\u7b2c 3 \u9636\u6bb5\u7528\u4e8e\u4ece\u66f4\u5927\u7684\u7fa4\u4f53\u4e2d\u6536\u96c6\u66f4\u591a\u5173\u4e8e\u6709\u6548\u6027\u548c\u5b89\u5168\u6027\u7684\u4fe1\u606f\uff0c\u5e76\u4e14\u8be5\u836f\u7269\u5c06\u5728\u6570\u5343\u4eba\u8eab\u4e0a\u8fdb\u884c\u6d4b\u8bd5\u3002<\/li>\n<\/ul>\n<p>\u5f53\u4e00\u4e2a\u516c\u53f8\u521b\u9020\u4e00\u79cd\u65b0\u836f\u65f6\uff0c\u4ed6\u4eec\u6709\u5fc5\u8981\u5728\u52a8\u7269\u8eab\u4e0a\u6d4b\u8bd5\u8fd9\u79cd\u836f\u7269\uff0c\u4ee5\u786e\u5b9a\u8be5\u836f\u7269\u662f\u5426\u5b89\u5168\u6709\u6548\u3002\u8fdb\u884c\u6b64\u6d4b\u8bd5\u540e\uff0c\u5fc5\u987b\u5411 FDA \u63d0\u4ea4\u7814\u7a76\u6027\u65b0\u836f (IND) \u7533\u8bf7\u3002 IND \u5305\u62ec\u5df2\u8fdb\u884c\u7684\u7814\u7a76\u7ed3\u679c\uff0c\u5e76\u8981\u6c42 FDA \u6279\u51c6\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u8fd9\u4e9b\u8bd5\u9a8c\u6d89\u53ca\u4eba\u7c7b\u3002\u7533\u8bf7\u548c\u8fdb\u884c\u7684\u7814\u7a76\u7ed3\u679c\u7531 FDA \u5ba1\u67e5\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2>\u5ba1\u67e5\u548c\u4fdd\u5bc6\u534f\u8bae\u7533\u8bf7<\/h2>\n<p>\u7814\u7a76\u5b8c\u6210\u540e\uff0c\u836f\u54c1\u5236\u9020\u5546\u5c06\u9700\u8981\u6536\u96c6\u6240\u6709\u7814\u7a76\u6570\u636e\u5e76\u4e0e FDA \u4f1a\u9762\u3002\u5c06\u5ba1\u67e5\u6570\u636e\uff0c\u5e76\u63d0\u4ea4\u65b0\u836f\u7533\u8bf7 (NDA)\u3002 NDA \u5fc5\u987b\u5305\u62ec <em>\u5168\u90e8<\/em> \u4eba\u7c7b\u548c\u52a8\u7269\u6570\u636e\u6c47\u7f16\u3002\u4e00\u65e6\u6536\u5230 NDA\uff0cFDA \u6700\u591a\u53ef\u80fd\u9700\u8981\u4e24\u4e2a\u6708\u7684\u65f6\u95f4\u6765\u51b3\u5b9a\u4ed6\u4eec\u662f\u5426\u8981\u5bf9\u5176\u8fdb\u884c\u5ba1\u67e5\u3002<\/p>\n<p>\u5982\u679c FDA \u6279\u51c6 IND\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u5c06\u5f00\u59cb\u3002\u8fd9\u662f\u5206\u9636\u6bb5\u53d1\u751f\u7684\u3002\u7b2c\u4e00\u9636\u6bb5\u7528\u4e8e\u8bc4\u4f30\u836f\u7269\u7684\u5b89\u5168\u6027\uff0c\u5305\u62ec\u4e0e\u836f\u7269\u76f8\u5173\u7684\u526f\u4f5c\u7528\u3002\u7b2c\u4e8c\u9636\u6bb5\u4f7f\u7528\u66f4\u591a\u7684\u60a3\u8005\uff0c\u76ee\u7684\u662f\u83b7\u53d6\u6709\u5173\u836f\u7269\u5e2e\u52a9\uff08\u6216\u4f24\u5bb3\uff09\u67d0\u4e9b\u6761\u4ef6\u4e0b\u7684\u4eba\u7684\u4fe1\u606f\u3002\u7b2c\u4e09\u9636\u6bb5\u4f9d\u8d56\u4e8e\u6765\u81ea\u6570\u5343\u540d\u60a3\u8005\u7684\u6570\u636e\uff0c\u65e8\u5728\u4e86\u89e3\u8be5\u836f\u7269\u7684\u6709\u6548\u6027\u4ee5\u53ca\u5b83\u4e0e\u5176\u4ed6\u836f\u7269\u7684\u76f8\u4e92\u4f5c\u7528\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2>\u6807\u7b7e\u548c\u8bbe\u65bd\u68c0\u67e5<\/h2>\n<p>\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u540e\uff0c\u5236\u9020\u5546\u5c06\u5411 FDA \u63d0\u4ea4\u65b0\u836f\u7533\u8bf7 (NDA)\u3002\u63d0\u4ea4 NDA \u540e\uff0cFDA \u5fc5\u987b\u63a5\u53d7 NDA \u6216\u9a73\u56de\u5b83\u3002\u5982\u679c\u5b83\u88ab\u63a5\u53d7\uff0c\u90a3\u4e48 FDA \u5ba1\u67e5\u5c0f\u7ec4\u5c06\u8bc4\u4f30\u6536\u96c6\u5230\u7684\u5173\u4e8e\u8be5\u836f\u7269\u7684\u6240\u6709\u6570\u636e\u3002\u5982\u679c\u53d1\u73b0\u836f\u7269\u5b89\u5168\u6709\u6548\uff0c\u5c06\u5bf9\u5176\u6807\u7b7e\u8fdb\u884c\u5ba1\u67e5\uff0c\u4ee5\u786e\u4fdd\u5305\u542b\u6240\u6709\u76f8\u5173\u4fe1\u606f\u3002\u6279\u51c6\u524d\u7684\u6700\u540e\u4e00\u6b65\u662f\u68c0\u67e5\u751f\u4ea7\u8bbe\u65bd\u3002\u6279\u51c6\u540e\uff0c\u8be5\u836f\u7269\u7684\u4e0a\u5e02\u540e\u76d1\u6d4b\u5c06\u7ee7\u7eed\u786e\u4fdd\u8be5\u836f\u7269\u662f\u5b89\u5168\u7684\u3002<\/p>\n<p>\u5982\u679c\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 <em>\u505a<\/em> \u5ba1\u67e5 NDA \u5e76\u786e\u5b9a\u4e00\u5207\u770b\u8d77\u6765\u90fd\u4e0d\u9519\uff0c\u4e0b\u4e00\u6b65\u662f\u5ba1\u67e5\u836f\u7269\u7684\u6807\u7b7e\u3002\u836f\u7269\u6807\u7b7e\u9700\u8981\u5305\u542b\u6240\u6709\u76f8\u5173\u4fe1\u606f\uff0c\u5305\u62ec\u670d\u7528\u836f\u7269\u7684\u4efb\u4f55\u98ce\u9669\u548c\u526f\u4f5c\u7528\u3002<\/p>\n<p>\u4e0b\u4e00\u6b65\u5c06\u662f\u5ba1\u67e5\u5236\u9020\u836f\u7269\u7684\u8bbe\u65bd\u3002\u6700\u540e\uff0c\u5c06\u8fdb\u884c\u6700\u7ec8\u5ba1\u67e5\uff0c\u5e76\u51b3\u5b9a\u6279\u51c6\u6216\u62d2\u7edd\u8be5\u836f\u7269\u3002<\/p>\n<p>\u8bf7\u8bb0\u4f4f\uff0c\u6240\u6709\u8fd9\u4e9b\u9636\u6bb5\u52a0\u8d77\u6765\u53ef\u80fd\u957f\u8fbe\u6570\u5e74\u3002<\/p>\n<h2>\u5f53\u836f\u7269\u662f\u5371\u9669\u7684<\/h2>\n<p>\u867d\u7136\u8fd9\u4e2a\u8fc7\u7a0b\u53ef\u80fd\u975e\u5e38\u5168\u9762\uff0c\u4f46 FDA \u5e76\u4e0d\u603b\u662f\u505a\u51fa\u6b63\u786e\u7684\u51b3\u5b9a\uff0c\u7ed3\u679c\u5bfc\u81f4\u5371\u9669\u836f\u7269\u8fdb\u5165\u6d88\u8d39\u8005\u624b\u4e2d\u3002\u867d\u7136\u8bb8\u591a\u4eba\u8bf4\u60a8\u4e0d\u5e94\u8be5\u5728\u7ebf\u641c\u7d22\u836f\u7269\uff0c\u4f46\u60a8\u5f53\u7136\u5e94\u8be5\u968f\u65f6\u8fdb\u884c\u5c3d\u804c\u8c03\u67e5\u5e76\u5c06\u4efb\u4f55\u7591\u8651\u548c\u95ee\u9898\u62a5\u544a\u7ed9\u60a8\u7684\u533b\u7597\u4fdd\u5065\u63d0\u4f9b\u8005\u3002\u60a8\u8fd8\u60f3\u786e\u4fdd\u60a8\u7684\u533b\u751f\u77e5\u9053\u60a8\u76ee\u524d\u6b63\u5728\u670d\u7528\u7684\u6240\u6709\u836f\u7269\uff0c\u5373\u4f7f\u5b83\u4eec\u662f\u5728\u67dc\u53f0\u4e0a\u9500\u552e\u7684\uff0c\u8fd9\u6837\u60a8\u5c31\u53ef\u4ee5\u907f\u514d\u4efb\u4f55\u6f5c\u5728\u7684\u4e25\u91cd\u76f8\u4e92\u4f5c\u7528\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3>\u5371\u9669\u836f\u7269\u6e9c\u8d70<\/h3>\n<p>\u867d\u7136\u4e0a\u9762\u7684\u8fc7\u7a0b\u53ef\u80fd\u770b\u8d77\u6765\u5f88\u5f7b\u5e95\uff0c\u4f46 <a href=\"https:\/\/www.forbes.com\/sites\/matthewherper\/2015\/08\/25\/nine-explanations-for-why-the-fda-is-approving-almost-every-new-drug-application\/#427d193d2482\" target=\"_blank\" rel=\"noopener\">FDA \u51e0\u4e4e\u6279\u51c6\u4e86\u6240\u6709 NDA<\/a> \u5b83\u5f97\u5230\u4e86\u3002\u8bb8\u591a\u56e0\u6709\u7f3a\u9677\u7684\u836f\u7269\u800c\u906d\u53d7\u4e25\u91cd\u4f24\u5bb3\u7684\u60a3\u8005\u53ef\u4ee5\u8bc1\u660e\uff0c\u5371\u9669\u836f\u7269\u7ecf\u5e38\u901a\u8fc7\u5ba1\u6279\u7a0b\u5e8f\u3002<\/p>\n<p>If you are harmed by a dangerous drug, contact the offices of Napoli Shkolnik  today. We can help you.<\/p>\n<h2>\u60a8\u53ef\u4ee5\u4fe1\u8d56\u7684\u5f8b\u5e08<\/h2>\n<p>\u5982\u679c\u60a8\u6216\u60a8\u6240\u7231\u7684\u4eba\u53d7\u5230\u5371\u9669\u836f\u7269\u7684\u4f24\u5bb3\uff0c\u6211\u4eec\u7684 <a href=\"https:\/\/napolilaw.lemonadestand.org\/zh\/%e8%81%94%e7%b3%bb%e6%88%91%e4%bb%ac\/\">\u6709\u7f3a\u9677\u7684\u5236\u836f\u4ee3\u7406\u4eba<\/a> \u53ef\u4ee5\u5e2e\u52a9\u3002\u4eca\u5929\u8054\u7cfb\u6211\u4eec\u4e3a\u60a8 <a href=\"https:\/\/napolilaw.lemonadestand.org\/zh\/%e8%81%94%e7%b3%bb%e6%88%91%e4%bb%ac\/\">\u514d\u8d39\u54a8\u8be2<\/a>.\u6ca1\u6709\u4e49\u52a1\uff0c\u5982\u679c\u60a8\u5728\u5ba1\u67e5\u60a8\u7684\u6cd5\u5f8b\u9009\u62e9\u540e\u51b3\u5b9a\u7ee7\u7eed\uff0c\u5219\u6ca1\u6709\u9884\u4ed8\u8d39\u7528\u3002\u4e8b\u5b9e\u4e0a\uff0c\u6211\u4eec\u53ea\u6709\u5728\u8d62\u5f97\u60a8\u7684\u6848\u4ef6\u540e\u624d\u4f1a\u6536\u56de\u8d39\u7528\u3002<\/p>\n<p>\u56fe\u7247\uff1a\u533b\u666f<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Before a prescription drug can be sold in the United States, it must go through a rigorous approval process managed by the U.S. Food and Drug Administration (FDA). The point&#8230;<\/p>","protected":false},"author":3,"featured_media":7371,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[776],"tags":[],"class_list":["post-7370","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-litigation"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts\/7370","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/comments?post=7370"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts\/7370\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/media\/7371"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/media?parent=7370"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/categories?post=7370"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/tags?post=7370"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}