FDA Picks Eli Lilly, Regeneron for Fast-Track Manufacturing Review Pilot
The FDA has selected seven companies, including Eli Lilly and Regeneron, for its new PreCheck Pilot Program to accelerate manufacturing facility reviews.
The U.S. Food and Drug Administration has chosen Eli Lilly and Regeneron among the first seven companies to participate in its PreCheck Pilot Program, a new initiative designed to speed up the agency's review of new pharmaceutical manufacturing facilities, CNBC has learned.
The pilot program marks a significant shift in how the FDA approaches manufacturing oversight, potentially cutting the time it takes for drugmakers to bring new production sites online. Faster facility approvals could have downstream effects on drug supply chains and the speed at which new medicines reach patients.
Read more Tata Data Leak Exposes Apple iPhone 18 Pro Parts and Suppliers →
Eli Lilly and Regeneron are two of the most prominent names in the pharmaceutical industry, with Lilly riding surging demand for its weight-loss and diabetes drugs and Regeneron known for blockbuster treatments in oncology and eye disease. Their inclusion signals the FDA is targeting high-volume, high-stakes manufacturers for the early phase of the program.
The PreCheck initiative reflects broader pressure on the FDA to modernize its inspection and approval infrastructure. Domestic manufacturing capacity has become a national priority in recent years, driven by supply-chain vulnerabilities exposed during the COVID-19 pandemic and ongoing policy debates about U.S. dependence on foreign drug production.
Continue reading at US Top News and Analysis.
