{"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":"leitlinien-der-us-amerikanischen-fda-zur-regulierung-von-ki-medikamenten","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/us-fda-ai-drug-regulation-guidance\/","title":{"rendered":"US-amerikanische FDA gibt Leitlinienentwurf zum Einsatz von KI in regulatorischen\u2026 bekannt"},"content":{"rendered":"
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On January 6, 2025, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance titled \u201cConsiderations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.\u201d This draft guidance marks an important step toward integrating artificial intelligence (AI) into the regulatory decision-making process for drugs and biological products,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 risk-based framework<\/a> to evaluate the credibility and reliability of AI models in regulatory contexts.<\/p>\n

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The FDA\u2019s guidance highlights several critical components:<\/p>\n

1. A Risk-Based Credibility Framework<\/strong><\/h4>\n

AI models must be assessed based on their intended use, or 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

Key factors include:<\/p>\n

    \n
  • Performance criteria<\/li>\n
  • Risk mitigation strategies<\/li>\n
  • Tailored documentation requirements<\/li>\n<\/ul>\n

    2. Scope of AI Applications<\/strong><\/h4>\n

    The guidance focuses on AI’s role in nonclinical, clinical, post marketing, and manufacturing<\/strong> phases, specifically for regulatory decisions related to drug safety, effectiveness, and quality.
    \nExcluded from the guidance are:<\/p>\n

      \n
    • AI in drug discovery<\/li>\n
    • Applications enhancing operational efficiency without direct patient or study impacts<\/li>\n<\/ul>\n

      3. Early Engagement with FDA<\/strong><\/h4>\n

      The FDA strongly encourages sponsors to engage early, especially for higher-risk applications like post marketing pharmacovigilance.<\/strong> Clear documentation and alignment with the agency’s expectations are key to a smooth evaluation process.<\/p>\n

      4. Encouraging Innovation in Pharmacovigilance<\/strong><\/h4>\n

      To foster innovation, the FDA has also launched the Emerging Drug Safety Technology Meeting (EDSTM) Program,<\/strong> a platform for discussing new technologies and their potential applications in pharmacovigilance.<\/p>\n

      The FDA is calling on industry leaders, researchers, and other stakeholders to provide feedback on the draft guidance by April 7, 2025.<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

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      <\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

      Am 6. Januar 2025 ver\u00f6ffentlichte die US-amerikanische Arzneimittelbeh\u00f6rde FDA einen Entwurf einer Leitlinie mit dem Titel \u201c\u00dcberlegungen zum Einsatz k\u00fcnstlicher Intelligenz zur Unterst\u00fctzung regulatorischer Entscheidungen bei Arzneimitteln und Biologika\u201d. Dieser Entwurf stellt einen wichtigen Schritt zur Integration k\u00fcnstlicher Intelligenz (KI) in den regulatorischen Entscheidungsprozess f\u00fcr Arzneimittel dar.<\/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":"\nUS 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. Feedback due by April 7, 2025. 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