FDA’s New PreCheck Program Targets Faster, Stronger U.S. Pharma Manufacturing
SHERIDAN, WYOMING – August 8, 2025 – In a move aimed at reducing the nation’s dependence on overseas pharmaceutical production, the U.S. Food and Drug Administration (FDA) has launched PreCheck, a two-phase program designed to speed regulatory review and strengthen domestic drug manufacturing capacity.
A New Framework for Facility Readiness
PreCheck’s first stage, the Facility Readiness Phase, gives manufacturers more structured and frequent communication with the FDA at pivotal stages such as site design, construction, and pre-production. The process also incorporates Drug Master Files — detailed, facility-specific records that map layouts, workflows, and operations — to support earlier and more accurate regulatory evaluation.