{"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":"guia-de-regulacion-de-medicamentos-con-ia-de-la-fda-de-ee-uu","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/us-fda-ai-drug-regulation-guidance\/","title":{"rendered":"La FDA de EE. UU. anuncia un borrador de gu\u00eda sobre el uso de IA en..."},"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On January 6, 2025, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance titled \u201cConsiderations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.\u201d This draft guidance marks an important step toward integrating artificial intelligence (AI) into the regulatory decision-making process for drugs and biological products,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":"

      El 6 de enero de 2025, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) anunci\u00f3 la publicaci\u00f3n de un borrador de gu\u00eda titulado "Consideraciones para el uso de inteligencia artificial en el apoyo a la toma de decisiones regulatorias sobre medicamentos y productos biol\u00f3gicos". Este borrador de gu\u00eda marca un paso importante hacia la integraci\u00f3n de la inteligencia artificial (IA) en el proceso de toma de decisiones regulatorias sobre medicamentos y\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":[609,498,459,461,496],"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-guideline","tag-drug-development-regs","tag-innovation-health","tag-ai-driven","tag-market-authorization-regs"],"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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