Category: FDA regulations
How Project Optimus Is Reshaping Oncology Development A panel of experts at BIO 2025 explored the transformative impact of Project Optimus, a Read Now 
The New Era of Project Optimus Implications for Oncology Development Strategy Initially drafted in January 2023 and finalized in August 2024, Read Now 
FDA Issues Draft Guidance on Conducting Multiregional Oncology Trials Clinical regulation helps enable consistent study results Oncology trials are becoming more global. While 22% Read Now 
Navigating Project Optimus and the Rapidly Changing Oncology Development Landscape Imagine a world where cancer treatments are more effective while also being safer for patients. Read Now 
FDA Finalizes Project Optimus Guidance for Dosing and Expectations for First-in-Human Oncology Trials The past 18 months have been Read Now 
Navigating the Changing Landscape of Clinical Trials Takeaways from the Clinical Trials in Oncology East Coast I was thrilled to recently chair Read Now 
Catalyst Is Project Optimus Ready, Are You? Ensure your oncology program is Project Optimus ready What is Project Optimus? Project Optimus, an Read Now