Can the FDA’s PreCheck End Costly Drug Launch Delays?

FDA’s PreCheck pilot accelerates drug plant reviews, boosting US biologics production and cutting costly launch delays.

14 Aug 2025

The US Food and Drug Administration is rethinking how it greenlights drug manufacturing plants. Its new PreCheck pilot, announced August 7, 2025, promises to trim months from the approval timeline, especially for facilities that use fermentation to produce vaccines, insulin, and advanced biologics.

Instead of waiting until construction is complete, the FDA will work with manufacturers during the design and building phases. The idea is simple: catch and fix compliance issues early, before they stall a drug launch.

Major players are paying attention. AstraZeneca and Eli Lilly have backed the program while pouring billions into new American production sites. For companies racing to deliver new treatments, a head start on facility approval could mean a major competitive edge.

“This is a significant shift in regulatory thinking,” said one executive involved. “It lets us move faster and smarter without sacrificing safety.”

Supporters say PreCheck could also boost compliance by offering clearer guidance from day one. With Washington looking to shore up domestic supply chains, the pilot fits neatly into broader efforts to reduce dependence on foreign manufacturing.

Skeptics point out potential pitfalls. Some companies may be reluctant to share proprietary details so early. Others wonder whether the FDA can manage the added workload without slowing other reviews.

Still, the timing is hard to ignore. As demand for biologics climbs and global supply lines remain fragile, PreCheck could mark a turning point in how US drug plants get built, approved, and brought online. If it works, life-saving medicines could reach patients faster than ever.