FDA to Close Manufacturing Readiness Pilot to New Applicants in April 2027

The FDA on Thursday published a strategy document on helping sponsors of fast-moving drug and biologic programs get their manufacturing work ready in time, and said its pilot program on the subject will stop accepting new applications at the end of April 2027.

The agency announced the document in a Federal Register notice. It covers chemistry, manufacturing and controls (CMC) readiness for products with accelerated clinical development timelines, regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Under the current Prescription Drug User Fee Act agreement, PDUFA VII, which covers fiscal years 2023 through 2027, the FDA committed to four actions in this area: a CDER manual of policies and procedures, a pilot, a public workshop and a strategy document. According to the strategy document, its publication fulfills the last of the four.

Pilot ran below capacity

The CMC Development and Readiness Pilot (CDRP), which began in April 2023, offered sponsors of investigational drugs on accelerated timelines two extra CMC-focused Type B meetings plus faster follow-up discussions. The FDA said participation in the first three years was limited. CDER received 13 requests and accepted 5, and CBER received 8 and accepted 5, for 10 accepted products out of a possible 27.

The document cites an April 2024 survey by PhRMA and the Biotechnology Innovation Organization in which members named barriers to applying, including the limited number of spots, a rule that sponsors be at least two years from filing a marketing application, the effort of preparing a CMC development plan, concerns about signing a disclosure letter, and possible delays in acceptance decisions. The FDA said it then dropped the two-year rule, cut its maximum review time for pilot applications from 180 to 90 days and simplified the development plan requirement. Participation stayed below capacity, it said, although applications for CBER products rose substantially in the first four months of fiscal 2026.

Industry participants told a September 10, 2025 workshop that early, iterative feedback helped, but some said the pilot's extra meetings offered little beyond what breakthrough therapy, fast track and regenerative medicine advanced therapy designations already provide, according to the document.

What comes next

The FDA said that after reviewing these results it has determined it is not necessary at this time to develop or revise its internal procedures. Products already in the pilot will continue to be supported until their marketing applications are submitted or their investigational new drug applications are withdrawn. The agency said it will instead encourage sponsors to:

• Outline a CMC development plan earlier, identifying anticipated challenges and a preliminary timeline.
• Request an initial CMC-focused meeting, with follow-up CMC-only meetings as needed.
• Use Type D meetings and a meeting minute clarification pilot for faster answers to follow-up questions.

For regulatory flexibility, the document points to CDER's manual of policies and procedures on quality assessment for products in expedited programs, which allows options such as flexible process validation, marketing of clinical-scale batches in some cases and alternative stability approaches, and to CBER's May 2026 guidance on CMC flexibilities for cell and gene therapy products. The notice invites comments under docket FDA-2026-N-7232.