Day: February 5, 2026

For decades, pharmaceutical manufacturing steadily migrated overseas, leaving the U.S. dependent on fragile global supply chains. With the launch of the FDA PreCheck pilot program, the agency is offering manufacturers something long requested: regulatory predictability before product submission. FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by facilitating the construction of U.S.-based … Read more

What’s the real impact of the FDA’s post-market safety authorities on drug safety actions? A new analysis published in JAMA Internal Medicine explores how post-approval safety measures, including withdrawals, boxed warnings, and safety communications, have evolved since the FDA Amendments Act (FDAAA) of 2007. The findings challenge assumptions about how quickly safety issues are identified … Read more