Lessons Learned from the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program

The Duke-Margolis Institute for Health Policy will host a virtual workshop, in collaboration with U.S. Food and Drug Administration (FDA), 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 pilot 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.

This meeting is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [U19FD006602] totaling $5,192,495 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.