FDA Introduces ‘PreCheck’ Plan to Strengthen US Drug Facilities

The FDA Thursday announced a program that seeks to strengthen domestic drug manufacturing by increasing regulatory predictability and facilitating the construction of plants in the US.

The program, dubbed “FDA PreCheck,” would accelerate the establishment of high priority pharmaceutical manufacturing facilities, according to a notice published Thursday in the Federal Register. It would consist of a two-stage approach: a facility readiness phase and an application submission phase.

The program follows President Donald Trump’s executive order issued in May. The order directs the Food and Drug Administration to maximize the timeliness and predictability of agency review and accelerate the development of domestic drug manufacturing.

The agency announced Thursday that it’s also seeking public comment on regulatory hurdles in establishing new facilities.

The FDA said it will hold a hybrid public meeting Sept. 30, where it will present a draft framework that seeks to facilitate onshoring of drug and biologic products.

More than half of the pharmaceuticals distributed in the US are manufactured overseas, according to the FDA. As of June 2025, approximately 53% of brand drug products and 69% of generic products have at least one manufacturer outside of the US.