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.”
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
