On August 7, 2025, the US FDA announced a new FDA PreCheck program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and making it easier to build manufacturing facilities in the US.[1][2] More than 50% of drugs distributed in the US are manufactured abroad, and only 11% of active pharmaceutical ingredient (API) manufacturers for FDA-approved products are in the US.[1][2] The program was created in response to Executive Order 14293 of May 5, 2025, which mandates the simplification of domestic production assessment and the elimination of unnecessary regulatory requirements.[3][4] FDA PreCheck implements a two-phase approach: the first phase (Facility Readiness) provides more frequent contact with the FDA during design, construction and pre-production, including the submission of a Type V Drug Master File with information on operations and quality systems.[2] The second phase (Application Submission) streamlines the development of the chemistry, manufacturing and quality control section through preliminary meetings.[2] The FDA held a public meeting on September 30, 2025 on moving drug and biologics manufacturing to the US.[1][2] Beginning February 1, 2026, the FDA will begin accepting applications for the PreCheck pilot program, which will select a first group of plants based on compliance with national priorities, such as shortage or essential drugs.[5]