The US FDA has begun accepting applications for its pilot PreCheck program, which is designed to ease the process for pharma companies to build new manufacturing facilities in the US.
The program is intended to enhance communications between pharmas and the agency to make construction of new pharmaceutical factories go more smoothly.
PreCheck has two phases. In phase 1, known as the Facility Readiness phase, manufacturers will be in regular contact with the agency for early technical advice before opening through pre-operational reviews and utilization of a facility-specific Drug Master File. In phase 2, known as the Application Submission phase, the FDA and drugmakers will engage in pre-submission meetings and inspections to resolve issues and speed up evaluations of manufacturing information in an application.
The FDA said that at the outset, priority will be given to facilities that are making drugs for the US market, are innovative, and are manufacturing critical medicines.
Since President Trump took office in January 2025, many large drugmakers, including Eli Lilly (LLY), Johnson & Johnson (JNJ), Merck (MRK), Bristol Myers Squibb (BMY), AstraZeneca (AZN), and Novartis (NVS), have agreed to make significant investments in US manufacturing facilities.