Senior leaders reiterated that GCP expectations are geography-agnostic, and inadequate inspection access can render foreign ...

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integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance ...

The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good ...

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, ...

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) ...

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 ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "Data Integrity by Design and Pharma 4.0: Next-Gen Techniques to Approach GxP Systems, and FDA Compliance" training has been added to ResearchAndMarkets.com's offering.

Dublin, Aug. 17, 2026 (GLOBE NEWSWIRE)-- The "FDA Inspection Readiness in the AI Era 2026 (Aug 20th - Aug 21st, 2026)" has been added to ResearchAndMarkets.com's offering. As the U.S. Food and Drug ...