The FDA announced on January 21, 2026, that it will accept applications starting February 1, 2026, for the PreCheck Pilot Program to enhance regulatory predictability for new U.S. pharmaceutical manufacturing facilities.1
PreCheck aims to streamline facility assessments in advance of product applications, facilitating domestic manufacturing and aligning with national priorities like product types and innovation.1
The program incorporates stakeholder feedback from a September 2025 public meeting, promoting early engagement to create predictable pathways and protect patient safety.1
This initiative helps manufacturers avoid surprises on decision day by conducting PreCheck activities during facility development phases.1
Sources:
1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-precheck-implementation-roadmap