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 ...

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued General Correspondence Letters to two third-party testing companies in China after uncovering falsified or otherwise invalid ...

Recently, China's National Medical Products Administration (“NMPA”) released a new version of the Inspection Points for Clinical Trials of Medical Devices. This new rule replaces two previous versions ...

Fresh concerns have emerged about the platelet studies underpinning the FDA approval of ticagrelor, AstraZeneca's multibillion-dollar heart drug. A new BMJ investigation reveals data discrepancies, ...

The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging from mold to skirted testing procedures. A Sun Pharma plant in Gujarat, India ...

The FDA is stepping up its unannounced inspections of foreign manufacturing facilities. In a statement about the increase in inspections, the Food and Drug Administration did not report how many ...

This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...