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

The FDA recently announced an 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. Applications will be accepted beginning Saturday, April 1, 2023.