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Akin Gump

| less than a minute read

FDA PreCheck Pilot Program Launches, Clearing a Smooth Path to Approval

On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot program. The goal of the program is to strengthen the domestic pharmaceutical supply chain by making the review and inspection process more predictable for U.S.-based drug manufacturing facilities. FDA will select an initial cohort of new pharmaceutical facilities and begin conducting PreCheck activities in 2026.