The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...
A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...
Human data and samples are scientific gifts, and scientists must be stewards of them, ensuring that they are collected and ...
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 ...
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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.
What’s been overlooked is that the FDA already has the power to fix this. Without new legislation, pilot programs, or years ...
In research, digital images, including gel electrophoresis and Western blot images, are not only illustrations but central evidence of data, which must be verified and reproducible. Peer-reviewed ...
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