Overview

• The FDA unveiled PreCheck on August 7 to strengthen domestic drug supply chains by making regulatory reviews of new manufacturing sites more predictable.
• President Trump’s May executive order called for reduced duplicative requirements and greater timeliness in factory construction approvals.
• PreCheck will engage manufacturers continuously during design, construction and pre-production and require a comprehensive master file for each site.
• A public meeting in Silver Spring, Maryland, on Sept. 30 will feature the draft framework and solicit stakeholder feedback before finalizing procedures.
• Major pharmaceutical companies have pledged multibillion-dollar U.S. investments, but new plants typically take years to build and looming tariffs could intensify domestic shifts.