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FDA – Considerations for the use of artificial intelligence to support regulatory decision-making for drug and biological products

FDA has issued a draft guidance to provide recommendations to sponsors and other interested parties on the use of artificial intelligence (AI) and to produce information or data intended to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. It discusses the use of AI models in the drug product life cycle, where the specific use of the AI model is to produce information or data to support regulatory decision-making regarding safety, effectiveness, or quality for drugs. Comments can be submitted until 7th April 2025.

News reported on the 31st of January 2025 in Catapult’s regulatory round-up, read the entire report here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 mai 2025). FDA – Considerations for the use of artificial intelligence to support regulatory decision-making for drug and biological products. ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/13yez


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