Lexology August 13, 2025
The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing facilities. This initiative is part of the federal government’s broader effort to strengthen U.S. supply chain resilience and reduce reliance on overseas drug production. The program intends to offer drug manufacturers a more predictable and collaborative regulatory pathway, with the potential to shorten timelines for establishing U.S.-based facilities.
Currently, more than half of the pharmaceuticals distributed in the U.S. are manufactured abroad, and only approximately 11 percent of active pharmaceutical ingredient (API) manufacturers for FDA-approved products are located domestically. Recent supply chain disruptions have underscored the vulnerability of this arrangement and the need for...
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