{"id":7917,"date":"2025-01-14T15:30:08","date_gmt":"2025-01-14T15:30:08","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=7917"},"modified":"2025-01-14T16:21:37","modified_gmt":"2025-01-14T16:21:37","slug":"fda-proposes-draft-guidance-to-ensure-ai-credibility-in-drug-and-biologic-submissions","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/fda-proposes-draft-guidance-to-ensure-ai-credibility-in-drug-and-biologic-submissions\/","title":{"rendered":"FDA Proposes Draft Guidance to Ensure AI Credibility in Drug and Biologic Submissions"},"content":{"rendered":"

The FDA (Food and Drug Administration)<\/strong>, the regulatory body of the United States, has issued guidance draft on the advance credibility of AI Models used for drug and biological product submissions. <\/strong><\/p>\n

Additionally, the FDA has also issued preliminary guidance on the development and commercialization of medical devices<\/strong> with Artificial Intelligence (AI)<\/strong> throughout the product\u2019s entire lifecycle. These are the first guidelines published by the FDA on the topic of artificial intelligence, developed in response to the exponential growth of its use since 2016.<\/p>\n

Artificial Intelligence and the Growth of the Pharmaceutical Market<\/h3>\n

With the rapidly growing pharmaceutical AI market<\/strong>, it is crucial for regulatory bodies to take proactive measures. The AI market<\/a> in the pharmaceutical industry was valued at $1.51 billion<\/strong> in 2024 and is expected to reach $16.49 billion<\/strong> by 2034.<\/p>\n

Artificial Intelligence<\/strong> can be a powerful tool to generate data on the safety<\/strong>, efficacy<\/strong>, and quality<\/strong> of drugs<\/strong> and biological products<\/strong>, accelerating the development of new solutions for patients.<\/p>\n

Ensuring the Credibility of AI Models in Drug Regulation<\/h3>\n

AI<\/strong> credibility is a key focus for the FDA<\/strong> due to ethical issues and the challenges that Artificial Intelligence<\/strong> can pose for companies.<\/p>\n

This preliminary FDA<\/strong> guide aims to ensure that AI<\/strong> models used in pharmaceutical products are reliable and effective.<\/p>\n

The context of AI<\/strong> model usage\u2014how it is applied to solve specific issues\u2014is crucial to assess its credibility. Thus, the FDA<\/strong> proposes a risk-based framework to validate AI<\/strong> models and ensure trust in their results, aligning with its approach to analyzing pharmaceutical and biologic products with AI<\/strong>.<\/p>\n

Key Considerations for Using AI in Drugs and Biological Product submissions<\/h3>\n

In its draft guidance<\/a>, the FDA<\/strong> recommends that companies adopt a risk-based credibility assessment framework, consisting of seven essential steps to ensure the effectiveness of AI<\/strong> models in the sector:<\/p>\n

    \n
  1. Define the issue of interest<\/strong><\/li>\n
  2. Define the context of use for the AI model<\/strong><\/li>\n
  3. Assess the risk of the AI model<\/strong><\/li>\n
  4. Develop a plan to establish the credibility of the AI model within the context of use<\/strong><\/li>\n
  5. Execute the plan<\/strong><\/li>\n
  6. Document the results of the credibility assessment and discuss deviations<\/strong><\/li>\n
  7. Determine the suitability of the AI model for the context of use<\/strong><\/li>\n<\/ol>\n

    The FDA<\/strong> aims to provide guidance on the use of Artificial Intelligence<\/strong> to ensure the credibility of AI<\/strong> models, thereby promoting safe and effective innovations in the sector.<\/p>\n

    For more information about regulatory issues, ELS can help<\/strong>.<\/p>\n

    Please contact<\/a> your local ELS consultant or email: info@elssolutions.pt<\/p>\n","protected":false},"excerpt":{"rendered":"

    FDA releases comprehensive guidance draft with recommendations on the use of artificial intelligence to support regulatory decisions regarding the safety, efficacy, and quality of drugs and biologics.<\/p>\n","protected":false},"author":9,"featured_media":7920,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_joinchat":[],"footnotes":""},"categories":[101,108,107,105,54,106,61,102,95],"tags":[104,111,109,62,103,110],"class_list":["post-7917","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-artificial-intelligence","category-drugs","category-fda","category-general","category-guidance-draft","category-news","category-noticias-en","category-regulations","tag-anvisa-en","tag-artificial-intelligence","tag-fda","tag-news","tag-regulations","tag-united-states"],"yoast_head":"\nFDA releases comprehensive guidance draft on the use of AI<\/title>\n<meta name=\"description\" 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