BRIEF—US FDA outlines expedited CMC readiness pilot

A new pilot program has been announced by the US Food and Drug Administration, aimed at facilitating readiness for certain products with accelerated clinical development timelines.

The  Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program was outlined in the recent Prescription Drug User Fee Act (PDUFA)  commitment letter.

The agency said that sponsors participating in the pilot would receive product-specific CMC advice during product development, including two more “Type B” meetings.

From 1 April 2023 the agency will begin taking requests to participate in the program, with nine slots available.

To be eligible, programs must be intended to diagnose, treat, or prevent a serious disease or condition where there is an unmet medical need.

The process may require additional agency interactions during product development, and may include the use of “risk-based regulatory approaches allowing streamlining of CMC development,” the FDA said.