The FDA is launching FDA PreCheck – an initiative intended to streamline regulatory interactions for companies establishing new drug manufacturing facilities in the US.
“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said a statement from FDA Commissioner Marty Makary. “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.”
The program consists of two phases. In the facility readiness phase, the FDA will provide enhanced communication during facility design, construction, and pre-production. Companies will be encouraged to submit a Type V Drug Master File containing information on facility design, operations, quality systems, and management, which can be referenced in future drug applications. In the application submission phase, the program will offer pre-application meetings and early feedback on the Chemistry, Manufacturing, and Controls (CMC) section of drug applications, with the goal of improving the efficiency and predictability of the review process.
The program aligns with Executive Order 14293, which directed the FDA to streamline the review of domestic manufacturing facilities and “eliminate unnecessary regulatory requirements while maximizing review timeliness and predictability.”
A public meeting, “Onshoring Manufacturing of Drugs and Biological Products,” will be held on September 30, 2025, at the FDA’s White Oak Campus in Maryland, with virtual participation available. The meeting will present the draft framework for the PreCheck program and provide an opportunity for stakeholder discussion on its implementation.
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