The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
The FDA will start accepting applications for its PreCheck pilot program on Feb. 1, advancing an initiative designed to strengthen the domestic pharmaceutical supply chain.
Proposed in August 2025, PreCheck is part of the FDA’s response to President Donald Trump’s executive order on providing regulatory relief to promote domestic production of critical medicines. The FDA envisaged the program encouraging companies to build new manufacturing facilities in the U.S. through a two-step approach that provided early feedback on plants and streamlined one part of drug approval submissions.
On Wednesday, the FDA published a roadmap for implementing the program. The agency will accept applications to participate in PreCheck from Feb. 1 to March 1. FDA officials will select finalists on April 1 and give them one month to provide additional information. The deadline for selecting the initial group of PreCheck participants is June 30.
The FDA said it will choose participants based on their “overall alignment with national priorities 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.”
FDA officials plan to provide additional information when the application website goes live on Feb. 1. For now, many details are unknown. The FDA said it is revising the program based on feedback provided last year at a public meeting and during a written comment period. However, the agency has only spoken publicly at a high level about the feedback and what requests it is incorporating into the pilot.
“Overall sentiment regarding the PreCheck program was positive, with industry requesting early engagement during facility development phases,” the agency said in a statement. “FDA will create a more predictable regulatory pathway, accelerate domestic pharmaceutical manufacturing and protect patient safety through the implementation of the PreCheck Program.”
During last year’s consultations, manufacturers, service providers and trade groups welcomed PreCheck as a program that could reduce the risk of facility-related drug rejections. Yet respondents also called for clarity on specifics that they said would shape the program’s impact. The FDA has yet to expand publicly on the proposal it shared before the consultations.
The lack of updates means it is unclear whether the FDA has acted on respondents’ wish lists of regulatory reforms, some of which were outside the scope of the original proposal. Companies called for the FDA to extend the program to cover existing plants, decouple inspections from drug approval filings and update post-approval change rules. Generic drugmakers and contract manufacturers shared other requests.
While the FDA is yet to respond publicly, the agency’s line about PreCheck “facilitating the construction of manufacturing sites in the U.S. and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application” offers potential clues about the pilot’s scope.
