FDA’s New PreCheck Scheme to Boost US Manufacturing Commences Applications

FDA Policy / Pharma Manufacturing February 2, 2026

FDA’s new scheme to boost US manufacturing commences despite uncertainty

PreCheck Snapshot

• Program: FDA PreCheck
• Start Date: 1 February
• Goal: National Security
• US APIs: Only 11%
• Activities: Start 2026

The US Food and Drug Administration (FDA) will start accepting applications for the new PreCheck scheme that will streamline the introduction of new pharmaceutical manufacturing facilities in the US, commissioner Marty Makary confirmed.

The PreCheck programme was unveiled in June 2025. As per an update on the programme’s roadmap on 21 January, the FDA said it would begin accepting applications on 1 February.

National Security and Strategy

Concurring with the timeline via a post on X, Makary stated: “The FDA PreCheck program — which is designed to accelerate domestic manufacturing — will start accepting applications next week! This is a national security issue we are not ignoring.”

The PreCheck scheme is part of a strategy by the Trump administration to reduce overreliance on imports. Apart from knock-on effects from pricing agreements between the White House and drug companies, the PreCheck programme is the first FDA policy directed at bolstering US pharma manufacturing.

Phases: Facility Readiness and Application Submission

The scheme operates in stages to streamline facilities:

• Facility Readiness phase: The first stage allows frequent communication with the FDA to discuss facility design, construction, and pre-production. Companies will be encouraged to provide information on site operations layouts and quality control elements.
• Application Submission phase: The second portion focuses on chemistry, manufacturing, and controls.

The FDA said it will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Selection is based on a facility’s “overall alignment with national priorities,” including products intended for the US market or facilities that demonstrate innovation in development.

Analyst View: Uncertainty and Import Reliance

Diderik Stadig, sector economist for TMT and Healthcare at ING, told Pharmaceutical Technology that the programme looked “promising” on paper to streamline drug approvals.

“However, with the FDA facing budget cuts, its long-term impact remains to be seen. The press release also highlights a goal of reducing dependence on foreign drugs and APIs but achieving that will require a far more concerted effort, particularly in the area of generics.”
— Diderik Stadig, ING

More than half of pharmaceuticals distributed in the US are manufactured overseas. The country is particularly exposed in the active pharmaceutical ingredients (APIs) supply chain. Of the manufacturers that produce APIs used in FDA-approved products, only 11% are based in the US.