FDA and the Duke-Margolis Institute for Health Policy will host a virtual workshop on September 10, 2025 that will delve into the challenges and strategies for expedited chemistry, manufacturing, and controls (CMC) development. The meeting will feature perspectives from both industry leaders and FDA regulators, who will discuss best practices and lessons learned from the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program.

Event Highlights

FDA Insights: Gain a comprehensive understanding of the expedited CMC development program and pilot from FDA experts.
Industry Experiences: Hear firsthand accounts from featured sponsors about their experiences with the CMC Development and Readiness program.
Interactive Panel Discussions: Meaningful discussions between industry and FDA representatives to explore FDA policy and programs to facilitate expedited CMC development of Investigational New Drug products.

View the workshop agenda and register here.