Expedited clinical development programs often face challenges in accelerating and aligning Chemistry, Manufacturing and Controls (CMC) development activities. To speed up CMC development and readiness, the FDA introduces the CMC Development and Readiness Pilot (CDRP) program on the first of April 2023 providing more Agency interaction opportunities.
The pilot program targets products that have accelerated development timelines, and products that have Breakthrough therapy, Fast Track or Regenerative medicine Advance Therapy (RMAT) designation are eligible. Here, the FDA will provide product-specific CMC advice, including two additional CMC-focused Type B meetings and an additional limited number on CMC focused discussions based on readiness and defined CMC milestones.
How to apply
Starting April 1, 2023, FDA will accept requests to participate in the CDRP program, the number of selected proposals is however limited. If your product match the eligibility criteria and you are interested in participating in the pilot program, you should submit a request to participate in the pilot as an amendment to your Investigational New Drug (IND) application. The cover letter should state “Request to participate in the CMC Development and Readiness Pilot.”
To focus pilot resources, you should include a description of your CMC development plan describing the current state of CMC development including a timeline for CMC development, including ongoing activities aligned with the clinical development program.
The plan should cover the following CMC-related areas:
- Available product characterization and preliminary identification of critical quality attributes.
- Description of the current drug substance and drug product manufacturing process and control strategy along with a description of and plan for the proposed commercial scale manufacturing and control strategy.
- Identification of manufacturing facilities, including any contract facilities, accompanied by the facilities' recent inspection history.
- Plans for ensuring product availability for commercial launch.
- Drug substance and drug product stability assessment plan.
Additional agency interactions
Acceleration strategies may not lead to more timely approval if the CMC development is lagging. During the CDRP program, you will have the opportunity to discuss your product development strategies and goals with FDA review staff in during CMC-focused Type B meetings and a limited number of additional follow-up discussions where you can address questions or ask for clarifications arising from the meeting.
Early engagement and feedback on the CMC can help streamline activities in early clinical development which will support you in making better and more timely decisions as it is usually easier and less expensive to make changes in early development than later on.
CMC should not be the bottleneck of the development process. At NDA we have longstanding expertise within the technical documentation concerning the CMC of medicines, reach out to us by using the form below and we can discuss how you can develop your product with the end in mind.
