The FDA announced the launch of its 'PreCheck' program on August 7, 2025, to strengthen and speed up drug and active pharmaceutical ingredient (API) manufacturing at U.S. sites1345.
FDA PreCheck aims to increase regulatory predictability and streamline the review and approval process for new domestic manufacturing facilities—making construction and operation faster and easier135.
The initiative was developed in response to a Trump administration executive order, which also proposed imposing steep tariffs on pharmaceutical imports to encourage U.S.-based drug production13.
More than half of medicines and a significant share of APIs used in the U.S. are currently manufactured overseas, underscoring national security and supply chain concerns135.
PreCheck will include two phases:
a Facility Readiness Phase, to enhance communication at key stages like design and construction, and an Application Submission Phase, to streamline regulatory requirements on drug application components35.
Manufacturers will use a Type V drug master file (DMF) to submit comprehensive facility and quality management information, enhancing regulatory transparency and potentially shortening application times3.
The FDA anticipates this program will help reverse America's reliance on foreign drug manufacturing and support investments in new U.S.-based pharmaceutical facilities15.
Sources:
1. https://www.biopharmadive.com/news/fda-precheck-us-drug-pharmaceutical-manufacturing-trump-order/757085/
3. https://www.pharmtech.com/view/fda-moves-to-strengthen-drug-supply-chain-with-precheck-program
4. https://firstwordpharma.com/story/5987373
5. https://www.upi.com/Health_News/2025/08/07/FDA-Makary-PreCheck-drug-manufacturing/5831754588011/