{"id":8660,"date":"2022-05-03T12:59:33","date_gmt":"2022-05-03T16:59:33","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/what-does-fda-approved-really-mean\/"},"modified":"2022-08-18T21:16:04","modified_gmt":"2022-08-19T01:16:04","slug":"fda-%e6%89%b9%e5%87%86%e7%9a%84%e7%9c%9f%e6%ad%a3%e5%90%ab%e4%b9%89%e6%98%af%e4%bb%80%e4%b9%88","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/zh\/article\/fda-%e6%89%b9%e5%87%86%e7%9a%84%e7%9c%9f%e6%ad%a3%e5%90%ab%e4%b9%89%e6%98%af%e4%bb%80%e4%b9%88\/","title":{"rendered":"\u201cFDA \u6279\u51c6\u201d\u7684\u771f\u6b63\u542b\u4e49\u662f\u4ec0\u4e48\uff1f"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">\u5f53\u60a8\u5728\u4ea7\u54c1\u4e0a\u770b\u5230\u201cFDA \u6279\u51c6\u201d\u4e00\u8bcd\u65f6\uff0c\u5f88\u5bb9\u6613\u8ba4\u4e3a\u5b83\u5df2\u88ab\u653f\u5e9c\u673a\u6784\u9a8c\u8bc1\u4e3a\u5b89\u5168\u6709\u6548\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4f46\u8fd9\u5230\u5e95\u610f\u5473\u7740\u4ec0\u4e48\uff1f<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u5728\u672c\u6587\u4e2d\uff0c\u6211\u4eec\u5c06\u8ba8\u8bba\u201cFDA \u6279\u51c6\u201d\u7684\u5b9e\u9645\u542b\u4e49\u4ee5\u53ca\u83b7\u5f97 FDA \u6279\u51c6\u7684\u4ea7\u54c1\uff08\u7279\u522b\u662f\u836f\u54c1\uff09\u7684\u8fc7\u7a0b\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4e86\u89e3\u8be5\u8fc7\u7a0b\u4ee5\u53ca\u201cFDA \u6279\u51c6\u201d\u7684\u5b9e\u9645\u542b\u4e49\u53ef\u4ee5\u5e2e\u52a9\u60a8\u786e\u5b9a\u60a8\u662f\u5426\u53d7\u5230 FDA \u6279\u51c6\u4ea7\u54c1\u7684\u4f24\u5bb3\u3002<\/span><\/p>\n<h2><b>\u836f\u54c1\u5982\u4f55\u83b7\u5f97 FDA \u6279\u51c6\uff1f<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">\u4e00\u79cd\u836f\u7269\u5728\u7f8e\u56fd\u4e0a\u5e02\u4e4b\u524d\uff0c\u5fc5\u987b\u7ecf\u8fc7 FDA \u7684\u4e25\u683c\u5ba1\u6279\u7a0b\u5e8f\u3002 FDA \u5728\u6279\u51c6\u836f\u7269\u4e4b\u524d\u5fc5\u987b\u6ee1\u8db3\u8bb8\u591a\u8981\u6c42\uff0c\u5305\u62ec\uff1a<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u836f\u7269\u5fc5\u987b\u5b89\u5168\u6709\u6548\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u836f\u7269\u5fc5\u987b\u6839\u636e\u826f\u597d\u751f\u4ea7\u89c4\u8303 (GMP) \u751f\u4ea7\u3002 GMP \u662f\u4e00\u5957\u786e\u4fdd\u836f\u54c1\u6309\u7167\u8d28\u91cf\u6807\u51c6\u5b89\u5168\u751f\u4ea7\u7684\u6cd5\u89c4\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u836f\u7269\u5fc5\u987b\u6b63\u786e\u8d34\u4e0a\u6807\u7b7e\u3002\u6807\u7b7e\u5fc5\u987b\u5305\u62ec\u836f\u7269\u540d\u79f0\u3001\u5242\u91cf\u548c\u4f7f\u7528\u8bf4\u660e\u3002\u6807\u7b7e\u8fd8\u5fc5\u987b\u8b66\u544a\u4efb\u4f55\u6f5c\u5728\u7684\u98ce\u9669\u548c\u526f\u4f5c\u7528\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u836f\u7269\u5fc5\u987b\u9644\u6709\u60a3\u8005\u5305\u88c5\u8bf4\u660e\u4e66 (PPI)\u3002 PPI \u662f\u4e00\u4efd\u4e3a\u60a3\u8005\u63d0\u4f9b\u6709\u5173\u836f\u7269\u4fe1\u606f\u7684\u6587\u4ef6\u3002\u5b83\u5305\u62ec\u6709\u5173\u836f\u7269\u7528\u9014\u3001\u6f5c\u5728\u98ce\u9669\u3001\u526f\u4f5c\u7528\u548c\u670d\u7528\u65b9\u6cd5\u7684\u4fe1\u606f\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u5728\u65b0\u836f\u4e0a\u5e02\u4e4b\u524d\uff0c\u5236\u9020\u5546\u5fc5\u987b\u5411 FDA \u63d0\u4ea4\u7814\u7a76\u6027\u65b0\u836f\u7533\u8bf7 (IND)\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">IND \u662f\u7533\u8bf7\u5728\u4eba\u4f53\u4e2d\u6d4b\u8bd5\u65b0\u836f\u7684\u8bb8\u53ef\u3002 FDA \u5c06\u5ba1\u67e5\u7533\u8bf7\u5e76\u53ef\u80fd\u8981\u6c42\u63d0\u4f9b\u66f4\u591a\u4fe1\u606f\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u5982\u679c FDA \u540c\u610f\u8ba9\u5236\u9020\u5546\u6d4b\u8bd5\u8be5\u836f\u7269\uff0c\u5b83\u5c06\u88ab\u7f6e\u4e8e\u6240\u8c13\u7684\u4e34\u5e8a\u6401\u7f6e\u72b6\u6001\u3002\u4e34\u5e8a\u6682\u505c\u662f\u6307 FDA \u51fa\u4e8e\u5b89\u5168\u8003\u8651\u800c\u505c\u6b62\u4e34\u5e8a\u8bd5\u9a8c\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u5236\u9020\u5546\u8fd8\u5fc5\u987b\u5411 FDA \u63d0\u4ea4\u65b0\u836f\u7533\u8bf7 (NDA)\u3002 NDA \u662f\u4e00\u4efd\u5173\u4e8e\u8be5\u836f\u7269\u7684\u7efc\u5408\u62a5\u544a\uff0c\u5176\u4e2d\u5305\u62ec\u6765\u81ea\u4e34\u5e8a\u524d\u548c\u4e34\u5e8a\u7814\u7a76\u7684\u6570\u636e\u3002 FDA \u5c06\u5ba1\u67e5 NDA \u5e76\u53ef\u80fd\u8981\u6c42\u63d0\u4f9b\u66f4\u591a\u4fe1\u606f\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u5982\u679c FDA \u540c\u610f\u8ba9\u5236\u9020\u5546\u9500\u552e\u8be5\u836f\u7269\uff0c\u5b83\u5c06\u88ab\u7f6e\u4e8e\u6240\u8c13\u7684\u6700\u7ec8\u6279\u51c6\u6682\u505c\u9636\u6bb5\u3002\u6700\u7ec8\u6279\u51c6\u6682\u505c\u662f\u6307 FDA \u51fa\u4e8e\u5b89\u5168\u8003\u8651\u800c\u505c\u6b62\u9500\u552e\u836f\u7269\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u65b0\u836f\u7684\u5ba1\u6279\u8fc7\u7a0b\u53ef\u80fd\u9700\u8981\u5f88\u591a\u5e74\u3002 FDA \u53ef\u80fd\u4f1a\u5728\u6279\u51c6\u8fc7\u7a0b\u4e2d\u968f\u65f6\u8981\u6c42\u5236\u9020\u5546\u63d0\u4f9b\u66f4\u591a\u4fe1\u606f\u3002<\/span><\/p>\n<h2><b>\u201cFDA \u6279\u51c6\u201d\u662f\u4ec0\u4e48\u610f\u601d\uff1f<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">\u671f\u9650 \u201d<\/span><a href=\"https:\/\/www.fda.gov\/consumers\/consumer-updates\/it-really-fda-approved\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">FDA \u6279\u51c6<\/span><\/a><span style=\"font-weight: 400;\">\u201d\u7528\u4e8e\u63cf\u8ff0\u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\u7684\u4ea7\u54c1\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4f46\u662f\uff0c\u8fd9\u662f\u4ec0\u4e48\u610f\u601d\uff1f\u5728\u5927\u591a\u6570\u60c5\u51b5\u4e0b\uff0c\u8fd9\u4ec5\u610f\u5473\u7740\u5236\u9020\u5546\u5df2\u5c06\u6709\u5173\u4ea7\u54c1\u7684\u4fe1\u606f\u63d0\u4ea4\u7ed9 FDA \u5e76\u83b7\u5f97\u4e0a\u5e02\u8bb8\u53ef\u3002 <\/span><\/p>\n<p><b>FDA \u672c\u8eab\u5e76\u4e0d\u5b9e\u9645\u6d4b\u8bd5\u4ea7\u54c1\uff1b\u5b83\u4f9d\u8d56\u4e8e\u5236\u9020\u5546\u63d0\u4f9b\u7684\u6570\u636e\u3002<\/b><\/p>\n<h2><b>\u5982\u679c\u60a8\u53d7\u5230 FDA \u6279\u51c6\u7684\u4ea7\u54c1\u7684\u4f24\u5bb3\u600e\u4e48\u529e\uff1f<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">\u5982\u679c\u60a8\u53d7\u5230 FDA \u6279\u51c6\u7684\u4ea7\u54c1\u7684\u4f24\u5bb3\uff0c\u60a8\u53ef\u4ee5<\/span><a href=\"\/zh\/%e7%bb%83%e4%b9%a0%e5%8c%ba\/%e5%8c%bb%e8%8d%af%e8%af%89%e8%ae%bc\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"> \u63d0\u8d77\u8bc9\u8bbc<\/span><\/a><span style=\"font-weight: 400;\"> \u53cd\u5bf9\u5236\u9020\u5546\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA \u6709\u8bb8\u591a\u836f\u7269\u4e0a\u5e02\u524d\u5fc5\u987b\u9075\u5b88\u7684\u5b89\u5168\u6cd5\u89c4\uff0c\u5236\u9020\u5546\u6709\u8d23\u4efb\u9075\u5b88\u8fd9\u4e9b\u6cd5\u89c4\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u5982\u679c\u4ed6\u4eec\u4e0d\u8fd9\u6837\u505a\uff0c\u4ed6\u4eec\u53ef\u80fd\u8981\u4e3a\u4ed6\u4eec\u7684\u4ea7\u54c1\u9020\u6210\u7684\u4efb\u4f55\u4f24\u5bb3\u8d1f\u8d23\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6839\u636e\u5236\u9020\u5546\u662f\u5426\u505a\u51fa\u865a\u5047\u58f0\u660e\u6216\u672a\u7ed9\u51fa\u6b63\u786e\u7684\u670d\u836f\u8bf4\u660e\uff0c\u4e0d\u540c\u7684\u5f53\u4e8b\u4eba\u53ef\u80fd\u8981\u627f\u62c5\u8d23\u4efb\u3002<\/span><\/p>\n<h2><b>\u8054\u7cfb Napoli Shkolnik<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">\u5982\u679c\u60a8\u53d7\u5230 FDA \u6279\u51c6\u7684\u4ea7\u54c1\u7684\u4f24\u5bb3\uff0c\u8bf7\u52a1\u5fc5\u54a8\u8be2\u53ef\u4ee5\u5e2e\u52a9\u60a8\u786e\u5b9a\u662f\u5426\u6709\u6848\u5b50\u7684\u5f8b\u5e08\u3002 <\/span><a href=\"\/zh\/%e8%81%94%e7%b3%bb%e6%88%91%e4%bb%ac\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">\u8054\u7cfb Napoli Shkolnik \u7684\u56e2\u961f<\/span><\/a><span style=\"font-weight: 400;\"> \u4eca\u5929\u7684\u4e13\u4e1a\u4eba\u58eb\u514d\u8d39\uff0c\u65e0\u4e49\u52a1\u54a8\u8be2\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>\u5f53\u60a8\u5728\u4ea7\u54c1\u4e0a\u770b\u5230\u201cFDA \u6279\u51c6\u201d\u4e00\u8bcd\u65f6\uff0c\u5f88\u5bb9\u6613\u8ba4\u4e3a\u5b83\u5df2\u88ab\u653f\u5e9c\u673a\u6784\u9a8c\u8bc1\u4e3a\u5b89\u5168\u6709\u6548\u3002\u4f46\u8fd9\u5230\u5e95\u662f\u4ec0\u4e48\u2026\u2026<\/p>","protected":false},"author":3,"featured_media":8661,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[776],"tags":[964,971,972],"class_list":["post-8660","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-litigation","tag-personal-injury","tag-health-and-safety","tag-fda-recall"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts\/8660","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=8660"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts\/8660\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/media\/8661"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/media?parent=8660"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/categories?post=8660"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/tags?post=8660"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}