On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to ...
Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator reveals the details behind the company's ...
Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by ...
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 ...
The FDA described Palamur’s responses to these findings as “inadequate’ and started that they “do not provide assurance that ...
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 ...
Zydus Lifesciences Limited has informed stock exchanges that the United States Food and Drug Administration (USFDA) has ...
MORRISVILLE, N.C., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its third FDA inspection, further ...
PHILADELPHIA, Nov. 25, 2025 /PRNewswire/ -- Rx-360, the International Pharmaceutical Supply Chain Consortium, is proud to announce a strategic partnership with Leucine, an AI-powered platform ...
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