By calculating the proportion of adverse events reported for each drug ... of toxicities. The reporting terms utilized in MedDRA were gathered from various dictionaries, including the WHO Adverse ...

BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study ...

Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...

That’s because medical device manufacturers frequently fail to promptly report side effects caused by their wares to federal regulators, a new study says. About 3 in 10 adverse event reports for ...

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration ... with a mean late reporting rate at the manufacturer ...

Less than three-quarters of medical device-related adverse events are reported on time by their manufacturers.

A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year period.

For Judy Coleman, beloved dog Dougal was her reason to get up in the morning — he died within months of starting a new arthritis drug and now US authorities are warning of side effects.