A major FDA recall of everyday products across the Midwest is tied to possible contamination with rodent urine and feces.

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

Health care workers are changing how they counsel patients. Experts are using our database to support their research. And ...

The dataset powers our Rx Inspector tool, which lets you find the factories that made your generic drugs and their FDA ...

Federal inspectors found widespread insect activity and mold at a California pita bakery, leading the FDA to warn that its ...

Medical device manufacturers face a labyrinth of audit and inspection regimes, each with unique demands that can make global compliance feel like a high-stakes balancing act. This article examines the ...

PORTLAND, Ore. (KOIN) — Five years after Oregon voters approved Measure 110, decriminalizing the possession of small amounts of hard drugs, the state is still struggling to make good on its promise of ...

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans, the latest move by President Donald Trump’s ...

Drug diversion remains a persistent challenge for hospitals and health systems, putting both patient safety and workforce wellbeing at risk. The impact doesn’t stop there – diversion can also create ...