Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
FDA will be accepting requests to participate in the CDRP on April 1st, 2023.
What is the CDRP
CDRP aims to:
- Facilitate the expedited CMC development of products with expedited clinical development timeframes.
- Increase communication between FDA and sponsors.
- Provide patients with earlier access to these products
On October 31, 2022, FDA announced the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program for Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products. CBER and CDER will conduct the CDRP to facilitate CMC development of selected products under investigational new drug (IND) applications with expedited clinical development timeframes to help patients get access to these products sooner. Sponsors of INDs with accelerated clinical development timelines are invited to apply to the CDRP.
Sponsors of INDs accepted into the pilot will be able to discuss their CMC product development strategies and goals with FDA review staff during two predesignated Type B meetings. Sponsors will have an opportunity for follow-up discussions to address questions arising from the meetings or when additional clarifications are needed. This increased communication will help sponsors complete CMC activities for their accelerated drug development programs to support application submission and earlier patient access to these products.
How to Apply
Please see the Federal Register notice for information on eligibility criteria and what to submit in a request to participate in the pilot.
FDA will start accepting requests to participate in the CDRP program on April 1, 2023. No more than nine proposals per year will be selected, with approximately two-thirds being CBER-regulated products and one-third CDER-regulated products. The CDRP program will run through FY 2027 (for the duration of PDUFA VII).
Sponsors who are interested in participating in the pilot program should submit a request to participate in the pilot as an amendment to their IND. The cover letter should state “Request to participate in the CMC Development and Readiness Pilot.”
For questions about the CDRP Program for CBER: firstname.lastname@example.org
For questions about the CDRP Program for CDER: email@example.com