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USFDA's Notice: CMC Development & Readiness Pilot Program

Recently in a new program announced by the Food and Drug Administration (USFDA), a limited number of applicants will be able to participate in a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program.

Development programs for CBER- and CDER-regulated drugs and biologics intended to diagnose, treat, or prevent a serious disease or condition where there is an unmet medical need may have accelerated clinical development timelines.

FDA will accept applications for participation in the CDRP program starting April 1, 2023, and will select no more than nine proposals, approximately two-thirds of which will be CBER-regulated products and one-third will be CDER-regulated products.

The purpose of this program is to expedite the development of products under investigational new drug (IND) applications, where warranted, based on the likelihood that patients will benefit from earlier access to these products.

Sponsors participating in the pilot program will receive product-specific CMC advice from FDA during product development, including two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions based on readiness and defined milestones.

The CDRP will increase the communication between FDA and the sponsors to ensure that adherence to CMC requirements for marketing applications is understood mutually.


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