FDA Launches PreCheck Pilot to Accelerate U.S. Drug Manufacturing

The U.S. Food and Drug Administration has officially opened its PreCheck pilot program designed to strengthen domestic pharmaceutical manufacturing by expediting the development and regulatory review of new U.S.-based drug production facilities. The initiative prioritizes facilities aligned with national needs and innovative technologies, aiming to reduce reliance on overseas drug supply chains.

Streamlining Onshoring for Critical Supply

The PreCheck pilot facilitates early and continuous FDA engagement throughout facility design, construction, and pre-production phases, helping companies resolve manufacturing and quality issues before formal drug applications. Facilities producing critical medications for the U.S. market will receive additional priority consideration.

Strategic Impact on U.S. Pharma Manufacturing

The program reflects broader federal efforts to reinvigorate domestic drug production and supply resilience, aligning with a recent Executive Order to promote onshoring of critical medicines. By reducing regulatory unpredictability and barriers, the FDA hopes to attract more manufacturing investment and mitigate supply chain vulnerabilities exposed by global disruptions.