The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. This initiative is part of the federal government’s broader effort to strengthen U.S. supply chain resilience and reduce reliance on overseas drug production. The program intends to offer drug manufacturers a more predictable and collaborative regulatory pathway, with the potential to shorten timelines for establishing U.S.-based facilities.
Currently, more than half of the pharmaceuticals distributed in the U.S. are manufactured abroad, and only approximately 11 percent of active pharmaceutical ingredient (API) manufacturers for FDA-approved products are located domestically. Recent supply chain disruptions have underscored the vulnerability of this arrangement and the need for a more robust domestic manufacturing base.
Program Structure
The program will leverage a two-phase approach to facilitate the introduction of new pharmaceutical manufacturing facilities in the U.S.
Facility Readiness Phase
The first stage of FDA PreCheck is designed to give manufacturers more direct access to the agency during the earliest and most critical stages of facility development – design, construction and preproduction. The FDA will provide more frequent opportunities for communication and feedback, helping companies identify and address potential compliance issues before they become costly delays.
Manufacturers are encouraged to submit comprehensive, facility-specific information that can be referenced later in drug applications. This may include detailed site layouts, descriptions of manufacturing operations, elements of the facility’s pharmaceutical quality system, and quality management maturity practices. The FDA recommends that this information be submitted through a Type V Drug Master File (DMF). By consolidating facility data into a DMF, companies can streamline later submissions and reduce redundancy in application materials.
Application Submission Phase
The second stage focuses on the Chemistry, Manufacturing, and Controls (CMC) portion of a drug application. The FDA will offer pre-application meetings and provide early feedback on anticipated data needs, facility readiness and inspection planning. This early engagement allows the agency to front-load certain quality assessments and coordinate inspections in a way that shortens review timelines. The goal is to ensure that, by the time an application is filed, both the facility and the supporting documentation are already well-positioned for approval.
Industry Next Steps
Companies considering domestic expansion should review the program’s requirements, assess potential benefits and evaluate whether early engagement with the FDA would be advantageous. The FDA will host a public meeting, Onshoring Manufacturing of Drugs and Biological Products, on Sept. 30, 2025, at the agency’s White Oak Campus in Silver Spring, Maryland, with virtual participation available.
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