News Brief: FDA Announed FDA PreCheck

On August 07, 2025, the U.S Food and Drug Administration announced a new program called FDA PreCheck, a system that strengthens the pharmaceutical supply chain by increasing regulatory predictability while assisting in the construction of manufacturing sites in the United States.

The Prececk Plan has two phases:

1. The Facility Readiness Phase offers manufacturers more frequent FDA communication during key development stages—facility design, construction, and pre-production. It also encourages submission of facility-specific information through a Type V Drug Master File (DMF), covering site layout, Pharmaceutical Quality System elements, and Quality Management Maturity practices. This DMF can be incorporated by reference into a drug application.
2. The Application Submission Phase focuses on streamlining the Chemistry, Manufacturing, and Controls section through pre-application meetings and early feedback.

FDA will host a public meeting titled "Onshoring Manufacturing of Drugs and Biological Products" on September 30, 2025, from 9:00 AM to 4:00 PM at the FDA White Oak Campus in Silver Spring, Maryland, with virtual participation available. For more information visit the FDA website.