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FDA announces CDRP pilot to accelerate CMC readiness for cell and gene therapies
Summary
The CMC Development and Readiness Pilot (CDRP), launched April 1, 2023 as part of PDUFA VII, offers eligible CBER INDs in expedited programs additional CMC meetings and prioritized interactions to help align CMC development with accelerated clinical timelines.
Dr. Karen Knudsen summarized new FDA resources to help sponsors accelerate CMC work. She described the CMC Development and Readiness Pilot (CDRP), launched 04/01/2023 as part of PDUFA VII, which "should help facilitate expedited CMC development of cell and gene therapy products through increased communication with us." She explained the program provides eligible applicants two dedicated Type B CMC meetings in addition to existing meetings to reach mutual understanding of approaches needed to achieve CMC readiness for marketing applications.
Knudsen said CBER INDs with expedited programs such as breakthrough or RMAT designation are eligible and that additional eligibility requirements apply; she urged interested sponsors to consult the FDA website for application details and to contact FDA staff with questions.
