FDA Launches PreCheck Pilot Program To Strengthen Pharmaceutical Manufacturing

The U.S. FDA has launched the PreCheck pilot program to enhance the domestic pharmaceutical supply chain by improving regulatory predictability and facilitating the construction of manufacturing sites. FDA Commissioner Marty Makary emphasized the initiative aims to bring pharmaceutical manufacturing back to the U.S. The program will select new manufacturing facilities based on alignment with national priorities, with a focus on critical medications. The FDA incorporated industry feedback into the program design, aiming for early engagement and streamlined processes.