FDA’s PreCheck program offers a streamlined regulatory application process for US-based drug manufacturing.
RT’s Three Key Takeaways:
- FDA PreCheck Initiative: The FDA launched the PreCheck program to promote US-based drug manufacturing by increasing regulatory predictability and streamlining facility approval processes.
- Reducing Foreign Dependence: With only 11% of active pharmaceutical ingredient (API) manufacturers based in the U.S., the initiative aims to reduce national security risks tied to foreign drug supply reliance.
- Two-Phase Framework: FDA PreCheck includes a Facility Readiness Phase for early guidance and a Submission Phase for streamlining drug application reviews, with a public meeting scheduled for September 30, 2025 to discuss implementation.
The US FDA has launched FDA PreCheck, a new program it says will strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States.
More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for active pharmaceutical ingredients (APIs). Of the manufacturers that produce APIs used in FDA-approved products, only 11% are US manufacturers.
“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary, MD, MPH. “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America’s reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”
FDA PreCheck was developed in response to Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs FDA to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements while maximizing review timeliness and predictability. The PreCheck program introduces an innovative two-phase approach to facilitate new U.S. drug manufacturing facilities.
Two-Phases of PreCheck
First, the Facility Readiness Phase provides manufacturers with more frequent FDA communication at critical development stages, including facility design, construction, and pre-production. This phase also encourages companies to provide a comprehensive facility-specific information through a Type V Drug Master File (DMF), such as site operations layout and description, Pharmaceutical Quality System elements, and Quality Management Maturity practices. This facility-specific DMF can be incorporated by reference into a drug application as appropriate.
Second, the Application Submission Phase centers on streamlining development of the Chemistry, Manufacturing, and Controls section of the application through pre-application meetings and early feedback.
Public Information Meeting
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. The meeting will feature a presentation of the FDA PreCheck draft framework; stakeholder discussions on framework strengths and opportunities; and exploration of additional considerations to overcome current onshoring challenges relevant to FDA authority.
