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 ...

Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator reveals the details behind the company's ...

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...

MORRISVILLE, N.C., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its third FDA inspection, further ...

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