The U.S. Food and Drug Administration (FDA) on Sunday opened applications for its FDA PreCheck pilot program, aimed at strengthening the domestic pharmaceutical supply chain by improving regulatory predictability, supporting the build-out of U.S. manufacturing sites, and streamlining facility assessments ahead of drug applications.

FDA Commissioner Marty Makary said the initiative is part of broader efforts to reverse decades of offshore drug manufacturing and make the U.S. pharmaceutical sector more resilient and competitive.

Program Launch Timeline and Facility Selection Criteria

The FDA plans to select an initial group of new pharmaceutical manufacturing facilities and begin PreCheck activities in 2026.

Selection will be based on alignment with national priorities, including the type of products manufactured, stage of facility development, time to supply the U.S. market, and the use of innovative manufacturing approaches.

Facilities producing critical medicines for ...