A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...
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 ...
Veteran radiopharmaceutical executive joins to accelerate partnerships, regulatory alignment, and scalable growth in ...
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 ...
NDTV Profit on MSN
Aurobindo Pharma shares fall after USFDA flags severe contamination, data integrity failures
The USFDA further highlighted deficiencies in environmental monitoring in manufacturing areas, indicating gaps in ensuring controlled production conditions.
The USFDA completed a Pre-Approval Inspection at Enzene Biosciences, Alkem Laboratories’ subsidiary in Chakan, Pune, on 13th ...
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 ...
Alkem Laboratories faced a USFDA pre-approval inspection at its Chakan-based facility of Enzene Biosciences, resulting in a ...
What’s been overlooked is that the FDA already has the power to fix this. Without new legislation, pilot programs, or years ...
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