How FDA's PreCheck Pilot Aims to Speed Up US Drug Manufacturing

FDA has launched a PreCheck Pilot Program selecting seven pharma companies and CDMOs to build new US-based drug manufacturing facilities with earlier regulatory engagement and a more predictable approval path. Participants must commit to three years of manufacturing post-approval, with priority given to facilities addressing drug shortages and supply-chain vulnerabilities. If you're a CDMO or contract manufacturer, the FDA just created a fast-track window to build US capacity with predictable timelines—but you need to move now, as only seven slots were handed out and the commitment is binding for three years. Call customers with shortages or critical supply vulnerabilities this week; they're the ones the pilot prioritises.