{"id":7962,"date":"2025-01-22T17:28:34","date_gmt":"2025-01-22T09:28:34","guid":{"rendered":"https:\/\/regask.com\/?p=7962"},"modified":"2025-01-22T17:28:34","modified_gmt":"2025-01-22T09:28:34","slug":"%e7%be%8e%e5%9b%bdfda-ai%e8%8d%af%e5%93%81%e7%9b%91%e7%ae%a1%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/us-fda-ai-drug-regulation-guidance\/","title":{"rendered":"\u7f8e\u56fd FDA \u5ba3\u5e03\u5173\u4e8e\u76d1\u7ba1\u9886\u57df\u4eba\u5de5\u667a\u80fd\u5e94\u7528\u7684\u6307\u5bfc\u8349\u6848\u2026\u2026"},"content":{"rendered":"<div class=\"flex max-w-full flex-col flex-grow\">\n<div class=\"min-h-8 text-message flex w-full flex-col items-end gap-2 whitespace-normal break-words text-start [.text-message+&amp;]:mt-5\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"e019e190-82b2-4137-a598-8f941c192144\" data-message-model-slug=\"gpt-4o\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\n<div class=\"markdown prose w-full break-words dark:prose-invert light\">\n<p>On January 6, 2025, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance titled \u201cConsiderations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.\u201d This draft guidance marks an important step toward integrating artificial intelligence (AI) into the regulatory decision-making process for drugs and biological products, emphasizing safety, effectiveness, and quality assessments. Through this initiative, the FDA aims to establish a <a href=\"https:\/\/regask.com\/uk-cbd-public-list\/\">risk-based framework<\/a> to evaluate the credibility and reliability of AI models in regulatory contexts.<\/p>\n<div class=\"flex max-w-full flex-col flex-grow\">\n<div class=\"min-h-8 text-message flex w-full flex-col items-end gap-2 whitespace-normal break-words text-start [.text-message+&amp;]:mt-5\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"30ff894f-05e5-4853-9fe5-f143f87341e6\" data-message-model-slug=\"gpt-4o\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\n<div class=\"markdown prose w-full break-words dark:prose-invert light\">\n<p>The FDA\u2019s guidance highlights several critical components:<\/p>\n<h4><strong>1. A Risk-Based Credibility Framework<\/strong><\/h4>\n<p>AI models must be assessed based on their intended use, or <strong>context of use (COU),<\/strong> with varying levels of oversight and stringency depending on the potential impact on patient safety or study reliability.<\/p>\n<p>Key factors include:<\/p>\n<ul>\n<li>Performance criteria<\/li>\n<li>Risk mitigation strategies<\/li>\n<li>Tailored documentation requirements<\/li>\n<\/ul>\n<h4><strong>2. Scope of AI Applications<\/strong><\/h4>\n<p>The guidance focuses on AI&#8217;s role in <strong>nonclinical, clinical, post marketing, and manufacturing<\/strong> phases, specifically for regulatory decisions related to drug safety, effectiveness, and quality.<br \/>\nExcluded from the guidance are:<\/p>\n<ul>\n<li>AI in drug discovery<\/li>\n<li>Applications enhancing operational efficiency without direct patient or study impacts<\/li>\n<\/ul>\n<h4><strong>3. Early Engagement with FDA<\/strong><\/h4>\n<p>The FDA strongly encourages sponsors to engage early, especially for higher-risk applications like <strong>post marketing pharmacovigilance.<\/strong> Clear documentation and alignment with the agency&#8217;s expectations are key to a smooth evaluation process.<\/p>\n<h4><strong>4. Encouraging Innovation in Pharmacovigilance<\/strong><\/h4>\n<p>To foster innovation, the FDA has also launched the <strong>Emerging Drug Safety Technology Meeting (EDSTM) Program,<\/strong> a platform for discussing new technologies and their potential applications in pharmacovigilance.<\/p>\n<p>The FDA is calling on industry leaders, researchers, and other stakeholders to provide feedback on the draft guidance by <strong>April 7, 2025.<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"mb-2 flex gap-3 empty:hidden -ml-2\">\n<div class=\"items-center justify-start rounded-xl p-1 flex\">\n<div class=\"flex items-center justify-center rounded-lg text-token-text-secondary\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>2025\u5e741\u67086\u65e5\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d1\u5e03\u4e86\u4e00\u4efd\u9898\u4e3a\u201c\u5229\u7528\u4eba\u5de5\u667a\u80fd\u652f\u6301\u836f\u54c1\u548c\u751f\u7269\u5236\u54c1\u76d1\u7ba1\u51b3\u7b56\u7684\u8003\u91cf\u56e0\u7d20\u201d\u7684\u6307\u5bfc\u8349\u6848\u3002\u8be5\u6307\u5bfc\u8349\u6848\u6807\u5fd7\u7740\u5c06\u4eba\u5de5\u667a\u80fd\uff08AI\uff09\u878d\u5165\u836f\u54c1\u548c\u751f\u7269\u5236\u54c1\u76d1\u7ba1\u51b3\u7b56\u8fc7\u7a0b\u8fc8\u51fa\u4e86\u91cd\u8981\u4e00\u6b65\u2026\u2026<\/p>","protected":false},"author":30,"featured_media":7973,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,35],"tags":[459,461,496,498,609],"class_list":["post-7962","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-biotech-latest-insights","tag-innovation-health","tag-ai-driven","tag-market-authorization-regs","tag-drug-development-regs","tag-guideline"],"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 Draft Guidance on AI in Drug Regulation | RegASK<\/title>\n<meta name=\"description\" content=\"US FDA releases draft guidance on AI use in drug regulation. 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