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FDA announces Public Workshop on Lessons Learned From the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program

FDA is announcing a virtual-only public workshop entitled “Lessons Learned From the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program.”  This workshop, convened by the Duke-Robert J. Margolis, MD Center for Health Policy, will feature discussions on CMC aspects of expedited development, illustrating best practices and lessons learned from the CDRP.  The workshop will also provide a forum for industry and the public to make recommendations on expediting CMC development.

This workshop fulfills a commitment in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII) to hold a public meeting to discuss best practices and lessons learned from the CDRP pilot program. 

Date/time: The public workshop will be held virtually on September 10, 2025, from 1:00 p.m. to 5:00 p.m., eastern time

Registration: To register for the public workshop, please visit the following website: https://healthpolicy.duke.edu/events/lessons-learned-chemistry-manufacturing-and-controls-cmc-development-and-readiness-pilot-0

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