Newly surfaced inspection data from the first months of the FDA's Quality Management System Regulation (QMSR) shows a tough new reality for life sciences teams: investigators are no longer looking at ...

Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during ...

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

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 U.S. Food and Drug Administration has flagged data integrity, manufacturing and maintenance lapses at one of Dabur India's plants following an inspection earlier this year, according to an ...

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, ...

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 ...

The U.S. Food and Drug Administration (FDA) published a draft guidance—the first of its kind—consolidating its expectations for how drug manufacturers should respond to Form 483 inspectional ...

Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites.

In part two of their interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explained why time savings ...

Dabur India has come under scrutiny after the United States Food and Drug Administration (US FDA) reportedly identified several deficiencies at one of the company's manufacturing facilities located at ...

In pharmaceutical manufacturing, inspection plays a critical role in process control to examine individual products, primary ...