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 ...
After IPTW adjustment, OAC discontinuation was linked to a higher incidence of thromboembolism (0.86 vs. 0.37 per 100 ...
BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study ...
In 2021, the American Society of Pharmacovigilance (ASP) launched the Fourth Cause Campaign to raise awareness that adverse drug events (ADEs) were the fourth leading cause of death in the United ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
A protocol for transitioning patients with heart failure and a left ventricular assist device to a stepdown unit from the ICU ...
Although most manufacturer reports of medical device adverse events are reported on time, a considerable proportion ...