Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program September 10, 2025

https://www.fda.gov/drugs/news-events-human-drugs/lessons-learned-chemistry-manufacturing-and-controls-cmc-development-and-readiness-pilot-cdrp?utm_medium=email&utm_source=govdelivery Lessons Learned from the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program Date: Wed, Sept. 10, 2025; 1 - 5 p.m. ET 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. https://www.fda.gov/drugs/pharmaceutical-quality-resources/chemistry-manufacturing-and-controls-development-and-readiness-pilot-cdrp-program?utm_medium=email&utm_source=govdelivery