Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last ...

BETHESDA, MD – Data integrity issues were the primary reason for the US Food and Drug Administration’s (FDA) delay in approving abbreviated new drug applications (ANDAs) past their review goal date, ...

Minor data corruptions can be even more dangerous and costly than a data breach or attack because they often go undetected for long periods. Data corruption is usually caused by incorrect, outdated or ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the ...

A new research report from Yale School of Medicine offers an up-close look at how biased artificial intelligence can affect clinical outcomes. The study focuses specifically on the different stages of ...

Kathleen Hurley is the founder of Sage Inc., a tech company that offers SMB businesses infrastructure solutions and next-gen technology. As data becomes everything to everybody, it’s crucial to ...