2026.01.06Vol.9 No.1 FDA ICH E2B (R3) ICSR Reporting for the FDA will become a mandatory requirement as of April 1, 2026
2025.09.29Vol.8 No.4 FDA FDA CSA: Computer Software Assurance for Production and Quality System Software, Document issued on September 24, 2025
2025.05.17Vol.7 No.15 FDA Uploaded (Japanese Translate Version) 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 Draft Guidance for Industry and Other Interested Parties]
2025.05.14Vol.7 No.14 FDA 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 Draft Guidance for Industry and Other Interested Parties
2025.02.27Vol.7 No.8 FDA FDA: [Japanese Translate Version] DHAC Executive Summary - Total Product Lifecycle Considerations for GenAl Devices" --> uploaded [REFERENCE] 2025/2/27
2025.01.10Vol.7 No.3 FDA FDA: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. Document issued on 7-Jan-2025.
2024.11.02Vol.6 No.18 FDA FDA to Start Regulating AI, AI/ML and GenAI? (FDA Paper) : Introduce [Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP Work Together]
2024.04.02Vol.6 No.3 FDA FDA Breaking News-2: On April 1, 2024 (Mon), the FDA began accepting pre-marketing (IND study or IND-exempt BA/BE study) ADR reports on the ICH E2B (R3) ICSR electronic reports.
2024.01.17Vol.6 No.1 FDA Breaking News: On January 16, 2024, the FDA began accepting post-marketing reports on ICH E2B (R3) ICSR electronic reports.
