On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot program. The goal of the program is to strengthen the domestic pharmaceutical supply chain by making the review and inspection process more predictable for U.S.-based drug manufacturing facilities.
FDA will select an initial cohort of new pharmaceutical facilities and begin conducting PreCheck activities in 2026. A new manufacturing facility is one that is not an existing facility or an extension of an existing facility and has broken ground, will break ground by the proposal deadline or is in pre-operational development, intended to produce human drugs and/or biological products. Selection for inclusion in the program will be based on a facility’s overall alignment with national priorities across several 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. Additional priority consideration will be given to facilities producing critical medications for the U.S. market. Companies must commit to actively manufacturing products in the facility assessed as part of the pilot program for at least three years after FDA approval of the products manufactured at the site during the pilot participation.
The FDA PreCheck program will consist of two phases. Phase 1 is called the “Facility Readiness Phase,” during which manufacturers who are selected for participation in the program will engage with FDA for early technical advice through pre-operational reviews and utilization of a facility-specific Drug Master File to facilitate evaluation of facility-specific elements to support the submission of a drug application before a facility is operational.
In Phase 2, the “Application Submission Phase,” FDA and the applicant will engage through pre-submission meetings and inspections to resolve issues and expedite assessments of manufacturing in support of a drug application.
The deadline for companies to submit requests to participate in the PreCheck pilot program is March 1, 2026. Finalists for participation in the PreCheck Program will be notified by April 1, 2026, with final selections to be made by June 30, 2026. FDA will select seven participants for the initial cohort.
For more information, companies can review the FDA PreCheck website.
