The U.S. Food and Drug Administration (FDA) has announced that it will begin accepting submissions for its new PreCheck Pilot Program, an initiative designed to strengthen the domestic pharmaceutical supply chain and encourage additional U.S.-based manufacturing. The FDA has indicated that applications will open on February 1, 2026, although the agency has not yet released the full set of program materials.
Key dates for the PreCheck Pilot Program include:
- February 1, 2026: FDA will release application information
- March 1, 2026: Initial application window closes
- April 1, 2026: FDA selects pilot program finalists and requests additional information
- May 1, 2026: Deadline for finalists to submit requested additional information
- June 30, 2026: FDA selects the initial cohort
Although industry comments and feedback urged the FDA to use the PreCheck Pilot to support expansion of manufacturing in both new and existing facilities, it appears the pilot will focus primarily on new facilities. The agency may consider factors such as alignment with national priorities, the stage of facility development, and the degree of technological innovation. FDA has also noted that the program is intended to provide a more efficient and predictable pathway for facility assessments. However, the agency has not yet provided guidance describing the expected contents of an application, the criteria it will use to evaluate submissions, or the timeline it will follow after the initial application period.
Companies interested in participating may face several challenges as they prepare. The short interval before applications open leaves limited time to gather documentation, and the lack of clarity around eligibility and review standards may make it difficult to determine whether specific facilities qualify. Preparing a submission may require deploying significant operational resources on a highly compressed timeline, and the process may be competitive.
In advance of FDA’s forthcoming guidance, companies may wish to review ongoing or planned facility projects to identify those that may align with the program’s objectives. It may also be helpful to begin compiling information that highlights innovation, potential benefits to domestic manufacturing, and contributions to the resilience of the U.S. supply chain. Additional detail is expected when FDA publishes its materials on February 1, and organizations should plan to monitor the agency’s website for updates.
Covington is closely monitoring developments related to the PreCheck Pilot Program. We assist clients in assessing eligibility, shaping application strategies and timelines, and preparing the regulatory and technical materials necessary for submission.
Please contact the following members of our Food, Drugs, and Devices practice for support as you prepare for the launch of the PreCheck Pilot Program.
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