How FDA's PreCheck Pilot Aims to Speed Up US Drug Manufacturing
DCAT reports that FDA has selected seven companies for its new PreCheck Pilot Program, designed to encourage US-based drug manufacturing through earlier engagement and a more predictable regulatory path.
DCAT Value Chain Insights recently published an article on the FDA's new PreCheck Pilot Program, which aims to encourage more drug manufacturing on US soil.
Launched in February 2026 following an executive order signed by President Trump in 2025, the program gives the FDA a way to engage earlier with companies building new domestic facilities, offering a more predictable path through the regulatory process. From more than 80 applicants, FDA selected seven participants: Amneal Pharmaceutical, Eli Lilly, Kriya Therapeutics, Kyowa Kirin, and Regeneron, along with CDMOs Cellares and Fujifilm Biotechnologies. Priority went to facilities addressing drug shortages, critical medicines, or supply-chain vulnerabilities, and to companies with proven manufacturing experience.
Participants must commit to manufacturing at the facility for at least three years after approval. FDA says it will track performance metrics and gather feedback throughout the pilot to shape whether and how the program could be scaled up more broadly.
Company
