August 8, 2025 – The FDA announced FDA PreCheck, a new program to strengthen the pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the U.S.
More than half of pharmaceuticals distributed in the U.S. are manufactured overseas. Further, the U.S. is reliant on overseas sources for active pharmaceutical ingredients (APIs). Of the manufacturers that produce APIs used in FDA-approved products, only 11% are U.S. manufacturers.
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.
The first phase, Facility Readiness Phase, provides manufacturers with consistent FDA communication at the critical stages of development, including facility design, construction and pre-production. The second stage is the Application Submission Phase, which centers on streamlining development of the chemistry, manufacturing, and controls section of the application.