The FDA’s PreCheck pilot program accelerates U.S. pharmaceutical manufacturing by streamlining facility construction and regulatory reviews.
Announced in 2025, PreCheck aligns with efforts to reshore drug manufacturing and reduce reliance on foreign supply chains.
The program may boost economic growth, with the potential to create jobs in advanced manufacturing and to accelerate nonresidential construction through faster project timelines and early FDA engagement.
The U.S. Food and Drug Administration (FDA) said in a statement February 1, 2026 that it had officially opened applications for its PreCheck pilot program, a groundbreaking initiative to accelerate the construction and regulatory review of pharmaceutical manufacturing facilities.
The program is a significant move to bolster the U.S. pharmaceutical supply chain and to revitalize domestic manufacturing, a key segment of nonresidential construction.
The FDA will begin selecting its first cohort of projects to move forward in 2026, with an exact date yet to be announced. The selection will focus on facilities that prioritize critical medicines, rapid market entry, and innovative manufacturing techniques.
The manufacturing sector had a strong year in nonresidential construction. ConstructConnect Chief Economist Michael Guckes reported in the January Construction Economy Snapshot that Manufacturing construction starts for the full-year 2025 were $107.5 billion, up 84.2 percent.
The FDA’s PreCheck program introduces a two-phase process designed to streamline regulatory engagement. In the first phase, manufacturers will receive early technical guidance during facility design and construction, leveraging tools like pre-operational reviews and facility-specific Drug Master Files.
The second phase focuses on expediting the review of quality systems and manufacturing information during drug application submissions.
FDA Commissioner Marty Makary, M.D., M.P.H., emphasized the program’s importance, stating, “After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back. 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 PreCheck program was introduced in response to a May 2025 executive order aimed at reducing reliance on foreign drug production, particularly from China and India.
ConstructConnect reported on the program in August 2025, highlighting its potential to reduce approval timelines and boost demand for contractors, engineers, and suppliers specializing in pharmaceutical and biotech facilities. The initiative could compress the typical five- to ten-year timeline for bringing new U.S. drug manufacturing capacity online.
If reshoring is successful, the PreCheck program could stabilize pharmaceutical supply chains, reduce regulatory bottlenecks, and invigorate nonresidential construction.
The FDA’s commitment to early engagement and modern manufacturing methods, such as digital modeling and modular builds, may shave months or even years off traditional timelines for advanced manufacturing facilities.
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