The FDA moved the Precheck program from planning to execution by clearing the first flight of a manufacturing pilot with seven biopharma companies participating. The initiative is designed to increase regulatory predictability and streamline plant assessments ahead of specific applications, supporting onshoring and pre-review readiness. Among the early cohorts, Eli Lilly and Regeneron are listed alongside companies including Cellares and Fujifilm, signaling the FDA’s intent to cover both large pharma and specialized manufacturing and tech providers. For developers planning CMC strategies, Precheck offers a structured path to reduce late-stage surprises tied to facilities. The FDA’s operational focus on earlier engagement aligns with broader CMC and quality expectations as sponsor supply chains expand and as more complex modalities move into late-stage development.