日本語訳版）FDA 「医薬品および生物学的製剤の規制判断を支援する人工知能（AI）の使用に関する考察」 （ドラフト）： FDA [Considerations for the Use of Artificial Intelligence to Support Regulatory Decision/Making for Drug and Biological Products. Draft Guidance for Industry and Other Interested Parties]
FDA : Considerations for the Use of Artificial Intelligence to Support Regulatory Decision/Making for Drug and Biological Products (Draft) , Draft Guidance for Industry and Other Interested Parties/ Docket Number:FDA/2024/D/4689
（日本語訳版）Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan_Japanese
