> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CMC Readiness Pilot Program
- URL: https://www.fdaweb.com/cmc-readiness-pilot-program/
- Published: 2023-09-11T12:00:00.000Z
- Updated: 2026-09-14T18:55:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155296

*Federal Register* notice: FDA is announcing an opportunity to participate in its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot program, which is intended to evaluate expedited CMC development for products offering clinical benefit through earlier patient access. The pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches. For sponsors participating in the pilot, the agency 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. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-09-11/pdf/2023-19502.pdf?ref=fdaweb.com).