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                        Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
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          Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) ProgramPharmaceutical Quality Resources Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
  
  	
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FDA will begin accepting requests to participate in year two of the CDRP on October 2, 2023.

*Federal Register Notice*


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 first 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 are continuing to 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. On October 2, 2023, FDA will begin accepting requests from sponsors who wish to participate in year two of 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 year two of the CDRP program on October 2, 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.”



**CONTACT INFORMATION**

For questions about the CDRP Program for CBER: industry.biologics@fda.hhs.gov

For questions about the CDRP Program for CDER: cder-opq-opro-crad-inquiries@fda.hhs.gov

                                                                                  Content current as of:
      09/11/2023
              
              
Regulated Product(s)
		 DrugsPharmaceutical Quality Resources

          
                        Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
          Search for Pharmaceutical Quality Documents
          Current Good Manufacturing Practice (CGMP) Regulations
          CDER Quality Management Maturity
          Q&A on CGMP Requirements
          Inspection | Enforcement Resources
          Questions and Answers on Quality-Related Controlled Correspondence
 
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