In 2019, FDA’s OCE initiated Project Orbis to provide a framework for concurrent submission and review of oncology drug products. Project Orbis Partners will provide an update on their recent collaboration and answer questions from the audience.
Learning Objectives
Provide an international regulatory update on Project Orbis; Discuss recent collaboration efforts beyond Project Orbis that were prompted by the initiative; Explain how sponsors can benefit from participating in Project Orbis.
Monday June 16, 2025 11:00am - 12:00pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
