FDA's PreCheck Strategy Faces Industry Pressure to Include Existing Drug Manufacturing Sites
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SHERIDAN, WYOMING - November 13, 2025 - Drug manufacturers are urging the FDA to broaden its proposed PreCheck program beyond new factory construction, warning that excluding existing facilities could slow U.S. efforts to expand pharmaceutical production capacity. At a recent agency meeting, representatives from companies spanning gene therapy, generics, and biologics argued that PreCheck's current scope overlooks the fastest route to alleviating drug shortages and strengthening domestic supply chains.
