FDA PreCheck Pilot Aims To Speed New Drug Manufacturing Plants And Reduce Shortages 

Washington, D.C. — Families dealing with medication backorders could see longer-term relief under a new federal pilot meant to accelerate the launch of U.S.-based drug manufacturing sites.

The U.S. Food and Drug Administration said Sunday it is now accepting requests to join “FDA PreCheck,” a pilot designed to increase predictability for manufacturers and streamline how the agency evaluates new pharmaceutical facilities before a company files a specific drug application. 

The agency plans to select an initial cohort of new manufacturing facilities and begin PreCheck activities in 2026. Selection will prioritize projects aligned with national needs, including what products will be made, how far along construction is, how quickly a site could supply the U.S. market and whether the facility uses innovative approaches. The FDA said extra consideration will be given to sites producing “critical medications” for the U.S. market. 

PreCheck is structured in two phases. In a “facility readiness” phase, selected manufacturers can receive early technical feedback and complete pre-operational reviews, including use of a facility-specific Drug Master File. In a second phase tied to an application submission, FDA and applicants build on that work through meetings and inspections intended to resolve issues earlier and speed review of manufacturing information. 

For parents, the program won’t change prescriptions overnight, but it’s aimed at reducing supply disruptions by helping new plants come online faster and with fewer surprises during review.

In the meantime, pharmacists recommend families ask about therapeutic alternatives if a medication is backordered, request refills early when possible and check FDA’s drug shortage updates for official status.

The FDA said eligibility and submission details are available on its PreCheck web pages, and it will announce selections as the pilot moves forward.