{"id":7921,"date":"2024-12-20T19:29:03","date_gmt":"2024-12-20T11:29:03","guid":{"rendered":"https:\/\/regask.com\/?p=7921"},"modified":"2024-12-20T19:29:03","modified_gmt":"2024-12-20T11:29:03","slug":"%e7%be%8e%e5%9b%bdfda%e7%9c%9f%e5%ae%9e%e4%b8%96%e7%95%8c%e8%af%81%e6%8d%ae%e4%b8%ad%e5%bf%83","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/us-fda-real-world-evidence-center\/","title":{"rendered":"FDA\uff08\u7f8e\u56fd\uff09\u5efa\u7acb\u65b0\u7684\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u4e2d\u5fc3\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2024 \u5e74 12 \u6708 12 \u65e5<\/strong>\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u5ba3\u5e03\u6210\u7acb <em>\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u4e0e\u521b\u65b0\u4e2d\u5fc3 (CRWEI)<\/em> \u836f\u54c1\u8bc4\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3 (CDER) \u7684\u804c\u80fd\u3002\u8fd9\u6807\u5fd7\u7740 FDA \u5728\u52a0\u5f3a\u6574\u5408\u80fd\u529b\u65b9\u9762\u8fc8\u51fa\u4e86\u91cd\u8981\u4e00\u6b65 <a href=\"https:\/\/regask.com\/zh\/%e7%8e%b0%e5%ae%9e%e4%b8%96%e7%95%8c%e8%af%81%e6%8d%ae-otc-%e7%b4%a2%e8%b5%94\/\"><strong>\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\uff08RWE\uff09<\/strong><\/a> \u836f\u7269\u8bc4\u4f30\u6d41\u7a0b\u3002\u901a\u8fc7\u5229\u7528\u771f\u5b9e\u4e16\u754c\u6570\u636e (RWD)\uff0cCRWEI \u65e8\u5728\u6539\u5584\u836f\u7269\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u548c\u4e0a\u5e02\u540e\u76d1\u6d4b\u7684\u8bc4\u4f30\u3002<\/p>\n<p>\u8be5\u4e2d\u5fc3\u7684\u6210\u7acb\u5f70\u663e\u4e86 FDA \u81f4\u529b\u4e8e\u5b9e\u73b0\u76d1\u7ba1\u6846\u67b6\u73b0\u4ee3\u5316\u4ee5\u9002\u5e94\u4e0d\u65ad\u53d1\u5c55\u7684\u79d1\u5b66\u65b9\u6cd5\u7684\u627f\u8bfa\u3002\u8be5\u4e2d\u5fc3\u5c06\u4e13\u6ce8\u4e8e\u63a8\u52a8 RWE \u5728\u76d1\u7ba1\u51b3\u7b56\u4e2d\u7684\u5e94\u7528\uff0c\u786e\u4fdd\u6cbb\u7597\u4ea7\u54c1\u7b26\u5408\u9ad8\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6807\u51c6\uff0c\u540c\u65f6\u52a0\u5feb\u521b\u65b0\u7597\u6cd5\u7684\u53ef\u53ca\u6027\u3002<\/p>\n<p>CRWEI \u7684\u9996\u8981\u4efb\u52a1\u662f\u4fc3\u8fdb <strong>\u5408\u4f5c<\/strong> \u4e0e\u5916\u90e8\u5229\u76ca\u76f8\u5173\u8005\uff08\u5305\u62ec\u5b66\u672f\u754c\u3001\u884c\u4e1a\u548c\u5176\u4ed6\u653f\u5e9c\u673a\u6784\uff09\u5408\u4f5c\uff0c\u63a8\u52a8 RWE \u7814\u7a76\u65b9\u6cd5\u7684\u521b\u65b0\u3002\u901a\u8fc7\u7b80\u5316 RWE \u4e0e\u76d1\u7ba1\u5b9e\u8df5\u7684\u6574\u5408\uff0c\u8be5\u4e2d\u5fc3\u5c06\u5728\u5236\u5b9a\u5404\u4e2a\u6cbb\u7597\u9886\u57df\u7684\u653f\u7b56\u548c\u6307\u5bfc\u5236\u836f\u516c\u53f8\u7684\u5408\u89c4\u671f\u671b\u65b9\u9762\u53d1\u6325\u5173\u952e\u4f5c\u7528\u3002<\/p>\n<p>CRWEI \u7684\u6210\u7acb\u4ee3\u8868\u7740\u4e00\u79cd\u66f4\u5e7f\u6cdb\u7684\u8f6c\u53d8\uff0c\u5373 <strong>\u6570\u636e\u9a71\u52a8\u7684\u533b\u7597\u76d1\u7ba1<\/strong>\uff0c\u8fd9\u9884\u793a\u7740\u5236\u836f\u516c\u53f8\u5728\u836f\u54c1\u5ba1\u6279\u8bc1\u636e\u63d0\u4ea4\u548c\u4e0a\u5e02\u540e\u627f\u8bfa\u65b9\u9762\u53ef\u80fd\u4f1a\u53d1\u751f\u53d8\u5316\u3002\u9f13\u52b1\u884c\u4e1a\u5229\u76ca\u76f8\u5173\u8005\u5bc6\u5207\u5173\u6ce8\u65b0\u6307\u5357\uff0c\u8c03\u6574\u63d0\u4ea4\u7b56\u7565\uff0c\u5e76\u53c2\u4e0e\u534f\u4f5c RWE \u7814\u7a76\uff0c\u4ee5\u7b26\u5408\u4e0d\u65ad\u53d8\u5316\u7684\u76d1\u7ba1\u671f\u671b\u3002<\/p>\n<p>\u9884\u8ba1\u8be5\u4e3e\u63aa\u5c06\u901a\u8fc7\u52a0\u901f\u83b7\u5f97\u6551\u547d\u6cbb\u7597\u7684\u673a\u4f1a\u540c\u65f6\u4fdd\u6301\u4e25\u683c\u7684\u836f\u7269\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u6807\u51c6\uff0c\u5bf9\u533b\u7597\u4fdd\u5065\u751f\u6001\u7cfb\u7edf\u4ea7\u751f\u79ef\u6781\u5f71\u54cd\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>On December 12, 2024, the U.S. Food and Drug Administration (FDA) announced the creation of the Center for Real-World Evidence and Innovation (CRWEI) within the Center for Drug Evaluation and Research (CDER). This marks a significant step in enhancing the FDA\u2019s ability to integrate real-world evidence (RWE) into drug evaluation processes. By leveraging real-world data&#8230;<\/p>","protected":false},"author":30,"featured_media":7938,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,35],"tags":[225,387],"class_list":["post-7921","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-biotech-latest-insights","tag-drug-safety","tag-real-word-evidence-rwe"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>US FDA&#039;s Center for Real-World Evidence Innovation | RegASK<\/title>\n<meta name=\"description\" content=\"US FDA launches a center to advance real-world evidence for drug safety and efficacy. 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