The U.S. Food and Drug Administration (FDA) on Sunday opened applications for its FDA PreCheck pilot program, aimed at strengthening the domestic pharmaceutical supply chain by improving regulatory predictability, supporting the build-out of U.S. manufacturing sites, and streamlining facility assessments ahead of drug applications.
FDA Commissioner Marty Makary said the initiative is part of broader efforts to reverse decades of offshore drug manufacturing and make the U.S. pharmaceutical sector more resilient and competitive.
Program Launch Timeline and Facility Selection Criteria
The FDA plans to select an initial group of new pharmaceutical manufacturing facilities and begin PreCheck activities in 2026.
Selection will be based on alignment with national priorities, including the type of products manufactured, stage of facility development, time to supply the U.S. market, and the use of innovative manufacturing approaches.
Facilities producing critical medicines for the U.S. market will receive additional consideration.
FDA PreCheck will roll out in two phases.
The Facility Readiness Phase provides early technical guidance through pre-operational reviews and a facility-specific Drug Master File, allowing the FDA to evaluate manufacturing elements ahead of a drug application.
The Application Submission Phase builds on this work through pre-submission meetings and inspections designed to resolve issues early and accelerate review of manufacturing information.
The FDA's PreCheck program is meant to speed up U.S. drug plant approvals and reduce supply-chain risk, creating new incentives for companies to invest domestically.
Eli Lilly Announces Major U.S. Manufacturing Investment
On Friday, Eli Lilly and Co. (NYSE:LLY) said it plans to invest more than $3.5 billion in a new manufacturing facility in the Lehigh Valley, Pennsylvania.
The site will serve as Lilly’s newest injectable medicine and device manufacturing facility that will produce next-generation weight-loss therapies, including retatrutide, an investigational GIP, GLP-1, and glucagon triple hormone receptor agonist.
This is the fourth new U.S. manufacturing site Lilly has announced since February 2025, as part of its commitment to bolster domestic medicine production.
Lilly will bring 850 jobs to the area. Construction, expected to begin in 2026, is anticipated to generate 2,000 construction jobs. The site will be operational in 2031.
LLY Price Action: Eli Lilly shares were up 1.70% at $1054.73 at the time of publication on Monday, according to Benzinga Pro data.
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