FDA opens fast-track program to speed U.S. drug plant construction

[FDA Approved Food and Drug Administration concept. Person using laptop with FDA icon on virtual screen for Health product standards control system.]
saifulasmee chede

The U.S. Food and Drug Administration started taking applications for its PreCheck pilot, a new effort to accelerate the construction and review of pharmaceutical manufacturing facilities in the United States.

Under the program, announced last year, the FDA will choose an initial group of projects in 2026 based on how closely they align with national priorities, including whether they produce critical medicines, how quickly they can reach the U.S. market and whether they use innovative manufacturing approaches.

PreCheck is designed to streamline regulatory oversight of domestic drug plants, consistent with President Donald Trump’s push to shift pharmaceutical manufacturing back to the U.S. The initiative uses a two-stage process. Early on, companies will have more frequent engagement with the FDA during facility design and construction. Later, regulators will offer earlier feedback on manufacturing and quality systems to speed approvals.

The launch follows other FDA efforts to shorten review timelines for drugs tied to national priorities. One such fast-track program promises decisions within one to two months for select medicines deemed vital to public health or national security.

However, that initiative has faced setbacks. Several drugs selected for expedited review have been delayed after FDA scientists raised safety or effectiveness concerns, according to prior reporting and internal documents.

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