FDA launched the first set of regulatory “PreCheck Rx” manufacturing pilot steps, clearing the initial flight involving seven biopharma companies for pre-assessment of facilities before product submissions. The program is designed to increase regulatory predictability for plant inspections tied to specific applications, supporting onshoring and earlier alignment on manufacturing readiness. The pilot takes place as the agency continues to reshape how it interfaces with plant assessment timelines—an area that has been a bottleneck for manufacturing expansions and scale-up execution. Companies participating are expected to gain clearer paths toward FDA plant assessments by coordinating review timing around intended submissions. Manufacturing and quality leaders will track whether PreCheck shortens overall cycle time and reduces later-stage CMC surprises, especially for cell and gene therapy platforms where facility readiness is often mission-critical.