Oct. 31, 2022

FDA Announces Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program

Today, FDA is announcing a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. As described in the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter , FDA is implementing this pilot program to facilitate CMC readiness for selected Center for Biologics Evaluation and Research (CBER)- and Center for Drug Evaluation and Research (CDER)-regulated products with accelerated clinical development timelines. For sponsors participating in the pilot, FDA will provide product-specific CMC advice during product development, to include two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions, based on readiness and defined CMC milestones.

Starting April 1, 2023, FDA will accept requests to participate in the CDRP program and select no more than nine proposals, with approximately two thirds being CBER-regulated products and one third CDER-regulated products. FDA will issue a new Federal Register notice to announce pilot programs for each of the three following fiscal years. See the “Participation” section for eligibility criteria, instructions on how to submit a request to participate, and selection criteria and process.

Development programs for CBER- and CDER-regulated drugs and biologics intended to diagnose, treat, or prevent a serious disease or condition where there is an unmet medical need may have accelerated clinical development timelines. Successfully expediting CMC readiness may require additional interactions with FDA during product development and, if applicable, warrant the use of science- and risk-based regulatory approaches allowing streamlining of CMC development activities, so that clinical benefits of earlier patient access to these products can be realized. The increased communication between FDA review staff and sponsors is intended to ensure a mutual understanding of approaches to completing CMC activities to ensure CMC readiness for a marketing application.

The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.

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