The FDA takes the next step with the PreCheck Pilot Program by providing a diagrammatic depiction of how it views selection for participation in the program will play out. The program is designed to effectuate Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs the FDA to “streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements while maximizing review timeliness and predictability.”
The FDA announced that it will begin accepting applications for inclusion in the pilot program starting on February 1, 2026. The roadmap appears below:
Once selections for inclusion in the pilot are made, the FDA has outlined two phases to the PreCheck Program here. “First, 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. Second, the Application Submission Phase centers on streamlining development of the Chemistry, Manufacturing, and Controls section of the application through pre-application meetings and early feedback.”
The FDA believes that the PreCheck Program will assist firms in building new domestic facilities and will, thus, also facilitate the onshoring of manufacturing capability in the U.S. We’ve already seen a number of firms either commit to or break ground on new domestic pharmaceutical manufacturing facilities since the program was first announced. The program will streamline the process by frequent and early interactions with, and guidance from, the Agency’s compliance arm to (hopefully) facilitate a shorter and smoother road to success. It will be interesting to see which companies are selected for inclusion in the initial pilot program.
