The FDA will begin accepting requests Oct. 1 from drug and biologics developers seeking to participate in the fifth year of its Chemistry, Manufacturing, and Controls Development and Readiness Pilot program.
The pilot, known as CDRP, is designed for products under investigational new drug applications that have expedited clinical-development timelines. It is intended to help sponsors prepare chemistry, manufacturing and controls information for potential marketing applications while their clinical programs advance.
FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research conduct the program. The agency first announced the pilot on Oct. 31, 2022.
Sponsors accepted into CDRP can discuss CMC development strategies and goals with FDA review staff during two predesignated Type B meetings. The agency said follow-up discussions may also be available when questions arise from those meetings or further clarification is needed.
The program is intended to increase communication between FDA and sponsors and support completion of manufacturing-related development work for products moving through accelerated clinical programs. CMC information addresses subjects such as how a product is made, controlled and maintained at appropriate quality standards.
FDA will select no more than nine proposals annually for the fifth program year. Approximately two-thirds of selected proposals will be for CBER-regulated products, including biologics, while approximately one-third will be for CDER-regulated products, including drugs.
The pilot is scheduled to continue through fiscal year 2027, the duration of the current Prescription Drug User Fee Act reauthorization period, known as PDUFA VII.
Sponsors must submit participation requests as amendments to their investigational new drug applications. The submission cover letter must state, “Request to participate in the CMC Development and Readiness Pilot.”
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