FDA announces CMC review pilot for drugs with expedited development

The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development and readiness pilot (CDRP) program to expedite the development of breakthrough products that address an unmet medical need.

FDA will accept nine applications for the pilot, which is slated to begin on 1 April 2023. Six of the slots will be reserved for products regulated by the Center for Biologics Evaluation and Research (CBER) and the remaining three will be for ones regulated by the Center for Drug Evaluation and Research (CDER). Applicants will be notified within 180 days of FDA’s receipt of applications.

Under the pilot, FDA will provide product-specific CMC advice during product development, including two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions.

FDA explained in a notice that products subject to speedy clinical development programs “may face challenges in expediting CMC development activities to align with the accelerated clinical timelines. Successfully expediting CMC readiness may require additional interactions with FDA during product development and, if applicable, warrant the use of science- and risk-based regulatory approaches allowing streamlining of CMC development activities, so that clinical benefits of earlier patient access to these products can be realized.”

The pilot was highlighted in the FDA Prescription Drug User Fee Act (PDUFA) VII commitment letter for fiscal years (FYs) 2023 through 2027.

Products that have breakthrough therapy, fast track or regenerative medicine advance therapy (RMAT) designation are eligible for the pilot. Sponsors must also have an active commercial IND in place, and such programs should not have reached the end of phase 2 at the time of application.

Sponsors interested in participating should submit a request in the IND cover letter. The cover letter should state “Request to participate in the CMC Development and Readiness Pilot.”

FDA will evaluate the anticipated clinical benefits of facilitating earlier access, the novelty of the product, the complexity of the manufacturing process, the sponsor's overall manufacturing experience and the sponsor's experience with the product.

FDA also said it may hold a public workshop and issue a strategy document incorporating lessons from the CDRP.

Federal Register notice

FDA announces CMC review pilot for drugs with expedited development

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