FDA Launches PreCheck Program

By Katie Anderson, Chief Editor, Pharmaceutical Online

The FDA is playing its hand at encouraging U.S. drug manufacturing with the launch of FDA PreCheck. The program introduces a two-phase approach to enable new U.S. drug manufacturing facilities: The Facility Readiness Phase and the Application Submission Phase.

1. Facility Readiness Phase

The FDA will participate in more frequent communication during this phase 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.

2. Application Submission Phase

This phase will streamline development of the Chemistry, Manufacturing, and Controls (CMC) section of the application through pre-application meetings and early feedback.

The PreCheck program was created in response to Executive Order 14293, which directs the FDA to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements while maximizing review timeliness and predictability. Is this the answer; facilitating the construction of new manufacturing sites? What about current sites in the U.S. that are being converted?

The FDA will host a public meeting to review the PreCheck program and other considerations titled "Onshoring Manufacturing of Drugs and Biological Products" on Sept. 30, 2025, from 9:00 AM to 4:00 PM at the FDA White Oak Campus in Silver Spring, Maryland, with virtual participation available.