On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...

In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA is still lagging woefully behind and is unable to approach its pre-COVID ...

In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...

The Food and Drug Administration is inspecting far fewer pharmaceutical companies conducting clinical research as it adjusts to the post-pandemic world and a smaller workforce, which an auditor warned ...

FDA is under fire for missing its mandated food safety inspection goals every year since 2018 and for reducing funds for state and local food safety programs The Government Accountability Office ...

An FDA investigator prepares a test sample for IMS analysis from a shipment of dietary supplements that arrived at the Port of Buffalo in Buffalo, N.Y. (FDA photo) The outbreak of COVID-19 has called ...