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Category: FDA regulations
Child on man's shoulders who is holding a kite with lots of sunshine The New Era of Project Optimus Implications for Oncology Development Strategy Initially drafted in January 2023 and finalized in August 2024, Read Now World Map on Night Sky Universe FDA Issues Draft Guidance on Conducting Multiregional Oncology Trials Clinical regulation helps enable consistent study results Oncology trials are becoming more global.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 woman holds pills and capsules in her hands Ensure Your Oncology Program Is Project Optimus Ready What is Project Optimus? Project Optimus, an initiative from the U.S. Food and Drug Administration Read Now Multicolored pills on white background. FDA Finalizes Project Optimus Guidance for Dosing and Expectations for First-in-Human Oncology Trials The past 18 months have been Read Now A smiling Keya Watkins gesturing at a podium at Clinical Trials in Oncology. Navigating the Changing Landscape of Clinical Trials Takeaways from the Clinical Trials in Oncology East Coast I was thrilled to recently chair Read Now Close up of colorful pills Catalyst is Project Optimus ready, are you? What is Project Optimus? Project Optimus, an initiative from the FDA, seeks to optimize dosing. Read Now