Silver Spring – The U.S. Food and Drug Administration is now accepting applications for the new PreCheck pilot program. The program aims to strengthen domestic pharmaceutical manufacturing, increase regulatory predictability, and facilitate the construction of new manufacturing facilities in the United States. It allows for an early, product-independent assessment of manufacturing facilities before a specific drug approval is sought.
FDA Commissioner Marty Makary stated that the program is a crucial step in reducing reliance on foreign manufacturing and making the supply chain more resilient. After 35 years of offshoring pharmaceutical production, PreCheck offers strong incentives to make U.S. manufacturing competitive and resilient again.
The program includes two phases: In Phase 1 (Facility Readiness Phase), selected manufacturers receive early technical advice through Pre-Operational Reviews and the use of a facility-specific Drug Master File. This facilitates the assessment of facility-specific elements before and during the approval review. Phase 2 (Application Submission Phase) builds on this and includes pre-submission meetings and inspections to resolve issues early and accelerate approval processes.
The selection of the first cohort of new manufacturing facilities will take place in 2026. Criteria include, among others, the products to be manufactured, the development stage of the facility, the timeline to market readiness for the U.S. market, and the degree of innovation. Priority will be given to facilities for critical medicines.
The program design is based on extensive industry feedback from the public hearing “Onshoring Manufacturing of Drugs and Biological Products” on September 30, 2025, as well as from comments in the Federal Register. The industry specifically requested early involvement during facility development and simplified documentation processes.
Further information on eligibility requirements and selection criteria is available on the FDA PreCheck website. The program is part of a broader strategy to promote domestic production and ensure long-term supply security for essential medicines.
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