Inconsistent reporting at a Pennsylvania site affected microbiological analyses of components and drug products that ...

The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance ...

Kivo reports a rise in FDA warning letters to drug firms due to documentation failures, with 94% citing recordkeeping issues.

The US Food and Drug Administration (FDA) has issued a draft guidance outlining how manufacturers can ensure the data integrity of bioavailability (BA) and bioequivalence (BE) studies to support ...

The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...

The Food and Drug Administration's (FDA) drug review arm has proposed withdrawing approval for Amgen Inc.’s AMGN Tavneos (avacopan), citing concerns over data integrity, lack of proven effectiveness, ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Data Process Mapping Tools and Strategies in Data Integrity Governance (Sept 5, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...

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, ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and potentially unreliable paper-based ...

A recent US Food and Drug Administration (FDA) warning letter to a contract drug-testing laboratory shows how incomplete records can expose deeper weaknesses in quality culture, investigation ...

Data integrity is an ongoing concern across all R&D organizations, no matter what part of the research lifecycle they’re navigating. These concerns extend beyond the potential for delayed timelines or ...

A regulated laboratory is any facility whose processes, records, or outputs are subject to oversight by a regulatory authority. In practice this covers Good Manufacturing Practice (GMP) quality ...