“PreCheck” Program to Boost U.S. Drug Manufacturing
Program supports facilities certification and drug submissions
FDA Announces New PreCheck Drug Manufacturing Program
The U.S. Food and Drug Administration (FDA) has announced the launch of FDA PreCheck, a groundbreaking new program designed to strengthen America’s domestic pharmaceutical supply chain by streamlining the development and approval of U.S.-based drug manufacturing facilities.
This initiative comes in response to Executive Order 14293, which calls for regulatory reform to promote the domestic production of critical medicines. Currently, more than 50% of pharmaceuticals distributed in the U.S. are manufactured overseas—and only 11% of API manufacturers for FDA-approved products are in the U.S.
“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary, M.D., M.P.H. “FDA PreCheck is one of many steps to reverse this trend and ensure a resilient, domestic drug supply.”
What Is FDA PreCheck?
The FDA PreCheck program introduces a two-phase approach aimed at making it easier for pharmaceutical manufacturers to build and launch new drug production facilities in the United States.
In the Facility Readiness Phase, manufacturers will benefit from more frequent and proactive communication with the FDA at key stages—ranging from facility design and construction to pre-production planning. This phase encourages companies to compile detailed, facility-specific information in a Type V Drug Master File (DMF).
This DMF may include the facility’s layout and operational structure, core elements of the pharmaceutical quality system, and practices that demonstrate the organization’s quality management maturity. Once submitted, this DMF can be referenced in future drug applications, helping to reduce redundancy and streamline approvals.
Following this is the Application Submission Phase, which focuses on accelerating the development and review of the Chemistry, Manufacturing, and Controls (CMC) portion of drug applications. Through early engagement, including pre-application meetings and timely FDA feedback, manufacturers will be better equipped to submit complete and review-ready applications.
Upcoming Public Meeting
To further support industry collaboration, the 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 an option to participate virtually. The meeting will introduce the draft PreCheck framework, gather stakeholder input on its strengths and areas for improvement, and explore additional strategies to address regulatory challenges that affect domestic pharmaceutical manufacturing.
Why It Matters
FDA PreCheck represents a meaningful shift in how the agency supports domestic pharmaceutical infrastructure. By increasing regulatory predictability and offering earlier engagement, the program lowers barriers for companies ready to invest in U.S.-based production of drugs and biologics—ultimately improving supply chain resilience, patient access, and national security.
More Information
Learn more about FDA PreCheck and register for the public meeting at FDA.gov or contact PublicEngagement@fda.hhs.gov. See the FDA precheck announcement.