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 FDA accepting requests to participate in CMC Development and Readiness Program FDA is now accepting requests from drug sponsors to participate in the fourth year of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. This pilot program, described in the FDA Prescription Drug User Fee Act (PDUFA) VII Commitment Letter for fiscal years (FYs) 2023 through 2027, facilitates CMC readiness for selected Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research-regulated products with accelerated clinical development timelines. For drug and biological product sponsors participating in the pilot, FDA will provide product-specific CMC advice during product development, including two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions, based on CMC readiness and defined milestones. The increased communication between FDA review staff and drug sponsors is intended to ensure a mutual understanding of approaches to completing CMC activities to ensure CMC readiness for a marketing application. https://www.federalregister.gov/documents/2025/08/28/2025-16513/chemistry-manufacturing-and-controls-development-and-readiness-pilot-program-program-announcement?utm_medium=email&utm_source=govdelivery