As the federal government pushes for lower drug prices and more domestic production, the FDA launched a “PreCheck” program Aug. 7 to expedite approval of new U.S. drug manufacturing facilities.
FDA PreCheck will provide drugmakers more frequent communication with the FDA at “critical development stages, including facility design, construction and pre-production,” the agency said.
The FDA will also encourage drug manufacturers to provide comprehensive, facility-specific information, which “can be incorporated by reference into a drug application as appropriate.”
Another phase of FDA PreCheck includes pre-application meetings and early feedback.
The program aligns with the Trump administration’s onshoring efforts. Several drugmakers and medical devicemakers have invested billions of dollars into constructing U.S.-based sites in recent months. Additionally, in June, the FDA announced a national priority voucher program to accelerate reviews of drug applications from companies “aligned with U.S. national priorities.”
