Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...
From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S.
The USFDA further highlighted deficiencies in environmental monitoring in manufacturing areas, indicating gaps in ensuring ...
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 ...
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 ...
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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