Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, ...
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 ...
In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) ...
Human data and samples are scientific gifts, and scientists must be stewards of them, ensuring that they are collected and ...
Detect pharmaceutical IP theft, ransomware campaigns, and supply chain breaches in real time with Morpheus AI SOC. The post ...
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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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.
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