The US Food and Drug Administration has announced that it is now accepting requests to join its new FDA PreCheck pilot program, a major initiative aimed at strengthening the domestic pharmaceutical supply chain.

 

The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites, and streamline certain aspects of facility assessments before specific drug applications.

 

"After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back," said FDA Commissioner Marty Makary. "The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive."

 

The FDA plans to select an initial cohort of new pharmaceutical manufacturing facilities and begin PreCheck activities in 2026. Facilities will be chosen based on alignment with national priorities, including the products they produce, their stage of development, speed to market, and innovation in facility design. Additional priority will be given to those manufacturing critical medications for the US market.

 

The program incorporates extensive industry feedback collected during the Sept 30, 2025, public meeting on “Onshoring Manufacturing of Drugs and Biological Products” and through Federal Register comments. Industry leaders strongly supported early engagement during facility development and streamlined documentation processes.

 

FDA PreCheck unfolds in two phases. Phase 1, the Facility Readiness Phase, allows selected manufacturers to receive early technical guidance from the FDA, including pre-operational reviews and facility-specific Drug Master Files to streamline later drug application evaluations. Phase 2, the Application Submission Phase, builds on this early engagement with pre-submission meetings and inspections to resolve issues and expedite review of manufacturing information.