Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program Opportunity

The Food and Drug Administration (FDA or Agency) is announcing the opportunity for a limited number of applicants to participate in a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, to facilitate the expedited CMC development of products under an investigational new drug (IND) application, where warranted, based upon the anticipated clinical benefit of earlier patient access to the products. 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. Starting April 1, 2023, FDA will accept requests to participate in the CDRP program. Learn more by clicking the link.