FDA Announces FDA PreCheck Implementation Roadmap

[1/21/2026] The U.S. Food and Drug Administration announced that it will begin accepting applications on February 1, 2026 for the FDA PreCheck Pilot Program. This program will strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.  

The FDA PreCheck Pilot Program will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting FDA PreCheck activities in 2026. These facilities will be selected based on overall alignment with national priorities such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. Additional details will be released on the application website on February 1, 2026. 

The FDA is incorporating stakeholder feedback into the program design based on comments made during the September 30, 2025 “Onshoring Manufacturing of Drugs and Biological Products” public meeting and public comments received through the Federal Register publication. Overall sentiment regarding the FDA PreCheck program was positive, with industry requesting early engagement during facility development phases. FDA will create a more predictable regulatory pathway, accelerate domestic pharmaceutical manufacturing, and protect patient safety through the implementation of the FDA PreCheck Program.

• Content current as of:

  01/21/2026

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