The U.S. Food and Drug Administration announced that it will begin accepting applications on February 1, 2026 for the PreCheck Pilot Program. This program will strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, 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.  

The PreCheck Pilot Program will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. These facilities will be selected based on 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. Additional details will be released on the application website on February 1, 2026. ..[FDA]