The US Food and Drug Administration (FDA) has announced that it is accepting requests to participate in the FDA PreCheck pilot program, 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 last 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 agency will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the US market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the US market. 

The PreCheck program consists of a two-phase approach to facilitate new US drug manufacturing facilities.  

The first phase, 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. 

Source: US Food and Drug Administration