After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
The FDA is ramping up oversight of foreign manufacturing sites by expanding its use of unannounced inspections, a move aimed at leveling the playing field between domestic and international drugmakers ...
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...
Government shutdowns lead to decreased predictability, causing delays in new submissions and manufacturing changes. Key risk ...
In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...
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