The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development and readiness pilot (CDRP) program to expedite the development of breakthrough products that address an unmet medical need.
FDA will accept nine applications for the pilot, which is slated to begin on 1 April 2023. Six of the slots will be reserved for products regulated by the Center for Biologics Evaluation and Research (CBER) and the remaining three will be for ones regulated by the Center for Drug Evaluation and Research (CDER). Applicants will be notified within 180 days of FDA’s receipt of applications.
Under the pilot, FDA will provide product-specific CMC advice during product development, including two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions…
