FDA launches PreCheck program to accelerate US drug manufacturing

The U.S. Food and Drug Administration has introduced FDA PreCheck, a new regulatory program designed to support construction of domestic pharmaceutical manufacturing facilities and reduce dependence on foreign drug production.

The initiative is part of the agency’s response to Executive Order 14293, which calls for regulatory relief to promote domestic production of critical medicines. According to the FDA, more than half of all drugs distributed domestically are manufactured overseas, and only 11% of active pharmaceutical ingredient (API) manufacturers for FDA-approved products are based in the U.S.

“Our gradual overreliance on foreign drug manufacturing has created national security risks,” FDA Commissioner Marty Makary said in a statement. “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”

FDA PreCheck introduces a two-phase pathway aimed at improving regulatory predictability for U.S.-based facilities. In the Facility Readiness Phase, companies will have increased opportunities for communication with FDA during site design and construction. The agency is encouraging the use of a Type V Drug Master File to submit facility-specific quality and design information for future reference in application filings.

In the Application Submission Phase, manufacturers can participate in pre-application meetings and obtain early feedback from the agency to expedite development of the Chemistry, Manufacturing, and Controls section of drug applications.

The FDA will present the draft framework at a public meeting, “Onshoring Manufacturing of Drugs and Biological Products,” scheduled for Sept. 30, 2025, at the FDA White Oak Campus in Silver Spring, Maryland. Virtual participation will also be available.