Get Ready for Project Optimus: Success Favors the Prepared
With the evolving regulatory landscape in oncology, we know that it is critical to stay on top of the latest news and be informed. We are continuously developing and curating up-to-date content on Project Optimus to help you understand the changes and implications for your oncology programs.
Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development
In this blog, I will reflect on why this agency guidance is so important for new oncology therapeutics.
Infographic- Project Optimus
What should oncology drug developers expect from the FDA’s Project Optimus?
How new Project Optimus may affect future of oncology clinical trials
What is the MTD approach? Why is the FDA now moving away from it?
What you should expect from FDA Project Optimus
What does this shift in dose optimization mean for you and what steps should you take?
FDA Project Optimus from a medical writing perspective
How does Optimus impact medical writing and submissions?
What is FDA's Project Optimus?
What are implications on Phase 1 programs and potential implications for products in Phases 2 and 3?
How you can prepare for for FDA’s Project Optimus
AAPS eChalk Talk on preparing for Optimus
Success favors the prepared | Applied Clinical Trials
Start asking the right questions to prepare for FDA’s dose optimization initiative.
How Optimus may affect future of oncology
What does Optimus mean for the future of the oncology drug pipeline?
