FDA PreCheck pilot program accepts applications, looks to speed up US buildouts

The U.S. Food and Drug Administration is accepting applications for an initial cohort of new pharmaceutical manufacturing facilities to participate in its PreCheck pilot program, which is meant to speed up domestic construction and increase regulatory predictability.

The application process for the pilot opened on Feb. 1 and will close March 1, with the goal of selecting finalists on April 1 and the initial group of participants to be chosen by June 30. The new pharmaceutical manufacturing facilities in the initial cohort will begin conducting PreCheck activities this year with pre-operational engagements starting July 1.

The selection of the facilities for the PreCheck pilot will be “based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development,” the agency said in Sunday’s announcement.

The FDA will give additional priority consideration to facilities producing critical medications for the domestic market. More than half of all drugs distributed domestically are manufactured overseas, and only 11% of active pharmaceutical ingredient (API) manufacturers are based in the U.S., according to the agency.

To be eligible for the PreCheck pilot program, a domestic site must be “an existing facility or an extension of an existing facility and has broken ground, will break ground by the pilot full proposal deadline, or is in the pre-operational development intended to produce human drugs and/or biological products.”

When it comes to facility size thresholds, the FDA said new manufacturing facilities that “produce sufficient volume to meet a specified market need (for example a small volume may be acceptable if it fully meets the needs for a rare disease state with a limited patient population) or contributes significantly to addressing U.S. market supply needs.”

The PreCheck pilot program will prioritize companies with past pharmaceutical manufacturing experience, which may be demonstrated through existing commercial facilities, partnerships in place with the appropriate manufacturing experience, or a plan for building the necessary in-house expertise.

“This may include both large and small manufacturers, and CDMOs that have agreements in place with experienced sponsors and a documented willingness to share information with their proposed partner sponsors about the proposed facility,” according to the FDA.

Among the requirements, companies must commit to submit an original New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA), or application supplement for drug substance (DS), FDF/drug product (DP), or a Type II Drug Master File (DMF) for small molecule APIs for the new manufacturing facility during the PreCheck pilot program.

Companies must also “actively” manufacture products in their facility for at least three years after FDA approval of the products manufactured at that site during the pilot.

Lowering US onshoring barriers

Launched in August 2025, PreCheck is part of the FDA’s response to President Donald Trump’s Executive Order 14293 which calls for regulatory relief to promote domestic production of critical medicines. The agency’s program takes a two-phase approach to help facilitate new U.S. drug manufacturing facilities and streamline aspects of facility assessments in advance of a specific product application.

In PreCheck’s Facility Readiness Phase, companies will have increased opportunities for communication with FDA during site design and construction. In PreCheck’s Application Submission Phase, manufacturers can participate in pre-application meetings and obtain early feedback from the agency to expedite development of the Chemistry, Manufacturing, and Controls (CMC) section of drug applications.

The FDA said it has “incorporated extensive industry feedback into the program design” based — in part — on comments made at a September 2025 public meeting on the proposed PreCheck framework, where companies expressed generally positive sentiments about the potential for reducing inspection-related delays and the promise of significantly de-risking timelines.

Broad strokes, few details

While intended to speed up U.S. drug facility construction, critics contend that the FDA’s PreCheck regulatory framework is short on detail and it remains to be seen whether the program boosts domestic manufacturing.

Puneet Souda, senior analyst and senior managing director at investment bank Leerink Partners, told Pharma Manufacturing that initially in September — when the FDA held its public meeting — PreCheck was “intriguing and seemed like a step in the right direction.” However, Souda believes pharmaceutical manufacturers are still looking for more certainty, stability, and assurance from the agency about the proposed framework.

“I don’t think that’s changed at all from last year. Is this going to accelerate something? Is this more on paper or is this more actionable? That’s where the challenge is,” he said.  “That’s where we’re stuck.”

Souda sees PreCheck as an expansion of an earlier, limited-scope FDA pre-approval facility evaluation pilot, with the new program formalizing and scaling that concept into a framework where companies would work with the agency while facilities are still being designed and built.

“We’ll see what they provide in the PreCheck program further,” he concludes. “A lot of this is uncertain.”