Expert comment: Swissmedic and swissethics position paper on safety considerations of FIH/early phase for clinical trials
Embarking on a First-in-Human (FIH) clinical trial is a pivotal moment in drug development, where scientific innovation meets ethical responsibility. For sponsors, this phase demands not only strategic planning but also commitment to participant safety, regulatory compliance, and data integrity. A guidance document published by Swissmedic and swissethics in September 2025 summarizes key sponsor and […]