By Ajay Babu Pazhayattil, Marzena Ingram, and Koti Reddy Bhimavarapu
This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.
The shift toward biologics, clinical trial globalization, and regulatory and commercial pressures places new stress on clinical supply chains. Service providers have responded with new capabilities.
Access the transcript from a recent Clinical Leader Live webinar where supply chain optimization experts shared best practices for streamlining shipments, reducing waste, and enhancing accountability.