Ensuring Patient Safety: FDA’s Draft Guidance on Assessing Overall Survival in Oncology Clinical Trials — A Multi-Perspective Analysis
Article 1. Regulatory Perspective The FDA’s August 2025 draft guidance outlines recommendations for evaluating Overall Survival (OS) in randomized oncology trials, particularly when OS isn’t the primary endpoint U.S. Food and Drug Administration. 2. Pharmacovigilance Perspective OS serves not only as efficacy but a critically objective safety endpoint. 3. MAH (Marketing Authorization Holder) Perspective From […]
Empowering Safe Innovation: FDA’s Predetermined Change Control Plan (PCCP) Guidance for AI-Enabled Medical Device Software Functions – A Regulatory, Pharmacovigilance, MAH, and Impact Perspective
1. Regulatory Perspective In April 2023, the FDA issued draft guidance introducing the Predetermined Change Control Plan (PCCP) framework. Its goal: to enable AI/ML-enabled device software functions (AI-DSFs) to be updated safely, effectively, and more swiftly, without requiring new submissions for each iteration Data Matters Privacy BlogU.S. Food and Drug Administration. These adjustments reflect the […]