Day: May 8, 2025

The FDA audits, particularly the unannounced or surprise inspections, are critical to ensure the integrity of the global drug supply chains. Unannounced FDA inspections at foreign facilities pose unique logistical, legal, and cultural challenges, leading to most foreign audits being announced weeks before they occur. This week, the FDA announced that it will expand unannounced … Read more

The executive order signed by President Donald J. Trump to promote American-made prescription drugs addresses a real and pressing issue. However, it oversimplifies the economic and structural factors behind the offshoring of drug manufacturing and misrepresents the nature of what kinds of pharmaceuticals are produced abroad versus domestically. The decision-making process for pharmaceutical manufacturing is … Read more