This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Category: Regulatory
A View of the Joint Clinical Assessment (JCA) Process An out-of-the-box solution to navigate regulation effectively The Joint Clinical Assessment (JCA) is a pivotal 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FDA Issues Draft Guidance on Conducting Multiregional Oncology Trials Clinical regulation helps enable consistent study results Oncology trials are becoming more global.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 
Impacts of Project Optimus on Oncology Trial Costs Exploring creative financial solutions for biotechs Navigating the evolving landscape of early-phase drug development has Read Now 
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 
Global Regulatory Strategy to Guide Your Oncology Program A well-planned regulatory strategy is critical to the successful launch of your product on a 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 
Catalyst Oncology Consulting Catalyst Oncology Consulting is focused solely on the development of new treatments in oncology. Catalyst Read Now 
Drug Development Strategy Workshops Catalyst Oncology offers the opportunity to assemble industry-leading experts in a dedicated full- or half-day Read Now