FDA Launches Pre-Check Program to Boost US-Based Drug Mfg
The US Food and Drug Administration (FDA) has announced FDA PreCheck, a new program the agency says is designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the US.
FDA PreCheck was developed in response to an Executive Order issued by President Donald Trump in May (May 2025) to streamline FDA review of pharmaceutical manufacturing facilities in the US, enhance the inspection process of foreign drug-manufacturing facilities, and streamline permitting of manufacturing facilities by the US Environmental Protection Agency.
The PreCheck program consists of a two-phase approach to facilitate new US drug manufacturing facilities.
The first phases, the Facility Readiness Phase provides manufacturers with more frequent FDA communication at critical development stages, including facility design, construction, and pre-production. This phase also encourages companies to provide a comprehensive facility-specific information through a Type V Drug Master File (DMF), such as site operations layout and description, Pharmaceutical Quality System elements, and Quality Management Maturity practices. This facility-specific DMF can be incorporated by reference into a drug application as appropriate.
The second phase, the Application Submission Phase, centers on streamlining development of the chemistry, manufacturing, and controls (CMC) section of the application through pre-application meetings and early feedback.
FDA will host a public meeting titled “Onshoring Manufacturing of Drugs and Biological Products” on September 30, 2025, from 9:00 AM to 4:00 PM at the FDA White Oak Campus in Silver Spring, Maryland, with virtual participation available. The meeting will feature a presentation of the FDA PreCheck draft framework, stakeholder discussions on framework strengths and opportunities, and exploration of additional considerations to overcome current onshoring challenges relevant to FDA authority.
