The FDA cleared the first flight of its PreCheck pilot, selecting seven companies for an early regulatory manufacturing assessment framework designed to increase predictability and support onshoring. The program is intended to streamline how the agency conducts plant assessments before a specific product application, potentially reducing time lost to manufacturing review cycles. The selected group includes major pharma and manufacturing stakeholders such as Eli Lilly, Regeneron, Amneal Pharmaceuticals and Cellares, among others, with additional participants named in the broader pilot cohort. PreCheck signals a shift toward earlier, structured engagement with manufacturing sites—particularly relevant for cell and gene therapy and other complex modalities where CMC issues can dominate timelines.