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# CMC Development and Readiness Pilot
- URL: https://www.fdaweb.com/cmc-development-and-readiness-pilot/
- Published: 2024-09-20T12:00:00.000Z
- Updated: 2026-09-14T14:41:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157822

*Federal Register* notice: FDA is announcing year three of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot. FDA designed the pilot program to assist with CMC readiness for CDER- and CBER-regulated products that have accelerated clinical development timelines. It features increased communication between the agency and sponsors and examines the use of science- and risk-based regulatory approaches. The notice outlines the eligibility criteria and process for submitting a request to participate in the program. To view the notice, click [here](https://public-inspection.federalregister.gov/2024-21674.pdf?ref=fdaweb.com).