{"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%b1%b3%e5%9b%bd-fda-%e3%83%aa%e3%82%a2%e3%83%ab%e3%83%af%e3%83%bc%e3%83%ab%e3%83%89%e3%82%a8%e3%83%93%e3%83%87%e3%83%b3%e3%82%b9%e3%82%bb%e3%83%b3%e3%82%bf%e3%83%bc","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/us-fda-real-world-evidence-center\/","title":{"rendered":"FDA (\u7c73\u56fd) \u304c\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u305f\u3081\u306e\u65b0\u3057\u3044\u30bb\u30f3\u30bf\u30fc\u3092\u8a2d\u7acb"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2024\u5e7412\u670812\u65e5<\/strong>\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001 <em>\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30a8\u30d3\u30c7\u30f3\u30b9\uff06\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u30bb\u30f3\u30bf\u30fc\uff08CRWEI\uff09<\/em> \u533b\u85ac\u54c1\u8a55\u4fa1\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\uff08CDER\uff09\u5185\u306b\u8a2d\u7f6e\u3055\u308c\u305f\u3002\u3053\u308c\u306fFDA\u306e\u7d71\u5408\u80fd\u529b\u3092\u5f37\u5316\u3059\u308b\u91cd\u8981\u306a\u4e00\u6b69\u3068\u306a\u308b\u3002 <a href=\"https:\/\/regask.com\/ja\/%e7%8f%be%e5%ae%9f%e4%b8%96%e7%95%8c%e3%81%ae%e8%a8%bc%e6%8b%a0-otc-%e3%82%af%e3%83%ac%e3%83%bc%e3%83%a0\/\"><strong>\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30a8\u30d3\u30c7\u30f3\u30b9\uff08RWE\uff09<\/strong><\/a> \u533b\u85ac\u54c1\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306b\u7d44\u307f\u8fbc\u3080\u3002CRWEI \u306f\u3001\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9 \u30c7\u30fc\u30bf (RWD) 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\u306e\u4f7f\u7528\u3092\u63a8\u9032\u3057\u3001\u6cbb\u7642\u88fd\u54c1\u304c\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u9ad8\u3044\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u306a\u304c\u3089\u3001\u9769\u65b0\u7684\u306a\u6cbb\u7642\u6cd5\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u8fc5\u901f\u5316\u3059\u308b\u3053\u3068\u306b\u91cd\u70b9\u3092\u7f6e\u304d\u307e\u3059\u3002<\/p>\n<p>CRWEI\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u512a\u5148\u4e8b\u9805\u306f\u3001 <strong>\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3<\/strong> \u5b66\u754c\u3001\u7523\u696d\u754c\u3001\u305d\u306e\u4ed6\u306e\u653f\u5e9c\u6a5f\u95a2\u3092\u542b\u3080\u5916\u90e8\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u3068\u5354\u529b\u3057\u3066\u3001RWE \u7814\u7a76\u65b9\u6cd5\u8ad6\u306e\u9769\u65b0\u3092\u63a8\u9032\u3057\u307e\u3059\u3002RWE 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<strong>\u30c7\u30fc\u30bf\u99c6\u52d5\u578b\u533b\u7642\u898f\u5236<\/strong>\u3053\u308c\u306f\u3001\u533b\u85ac\u54c1\u627f\u8a8d\u306e\u305f\u3081\u306e\u8a3c\u62e0\u63d0\u51fa\u3084\u5e02\u8ca9\u5f8c\u306e\u53d6\u308a\u7d44\u307f\u306b\u304a\u3044\u3066\u88fd\u85ac\u4f1a\u793e\u306b\u3068\u3063\u3066\u6f5c\u5728\u7684\u306a\u5909\u5316\u3092\u793a\u5506\u3057\u3066\u3044\u307e\u3059\u3002\u696d\u754c\u306e\u95a2\u4fc2\u8005\u306f\u3001\u65b0\u3057\u3044\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u6ce8\u610f\u6df1\u304f\u76e3\u8996\u3057\u3001\u63d0\u51fa\u6226\u7565\u3092\u9069\u5fdc\u3055\u305b\u3001\u9032\u5316\u3059\u308b\u898f\u5236\u4e0a\u306e\u671f\u5f85\u306b\u6cbf\u3046\u3088\u3046\u306b\u5171\u540c\u3067 RWE \u7814\u7a76\u306b\u53d6\u308a\u7d44\u3080\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>\u3053\u306e\u53d6\u308a\u7d44\u307f\u306f\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u95a2\u3059\u308b\u53b3\u683c\u306a\u57fa\u6e96\u3092\u7dad\u6301\u3057\u306a\u304c\u3089\u3001\u547d\u3092\u6551\u3046\u6cbb\u7642\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u52a0\u901f\u3059\u308b\u3053\u3068\u3067\u3001\u30d8\u30eb\u30b9\u30b1\u30a2 \u30a8\u30b3\u30b7\u30b9\u30c6\u30e0\u306b\u30d7\u30e9\u30b9\u306e\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3053\u3068\u304c\u671f\u5f85\u3055\u308c\u3066\u3044\u307e\u3059\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 (RWD), the CRWEI aims to improve the evaluation of drug safety, efficacy, and post-market surveillance. The establishment of this center underscores the FDA\u2019s commitment to modernizing regulatory frameworks to adapt to evolving scientific methodologies. It will focus on advancing the use of RWE in regulatory decision-making, ensuring that therapeutic products meet high standards of safety&#8230;<\/p>","protected":false},"author":43,"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 v28.0 (Yoast SEO v28.2) - 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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