2021.05.08Vol.3 No.6 FDA Summary Status of the FDA: Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device (GMLP)
2021.04.15Vol.3 No.4 FDA FDA: Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan (GMLP)
2021.02.14Vol.3 No.2 FDA Summary of the FDA PV Regulation in Feb-2021: ICSR Report by ICH E2B(R2)/(R3) at IND and Postmarketing
2020.02.08Vol.1 No.6 FDA Final rules and guidance on post-marketing safety reporting of FDA combination products (draft)FDA配合製品の市販後安全性報告に関する最終規則とガイダンス（ドラフト）
