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 ...
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 ...
Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...
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, ...
Data integrity is the backbone of every clinical trial, ensuring that research truly benefits patients and advances medical science. When information is accurate, complete, and transparent, doctors ...
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