Medical Device Network on MSN11d
Nearly a third of FDA medical device adverse event reports filed late
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 ...
Medscape9h
Isotretinoin in Acne: Risks Beyond Depression, Suicidality Evaluated
The study evaluates 20 years of the US Food and Drug Administration (FDA) Adverse Event Reporting System data.
MedTech Dive6d
Top device firms report safety data late: BMJ
BD, Medtronic and Abbott were among the top 10 device companies with the highest number of late reports to the FDA, the study ...
Medical Dialogues12h
Increased Risk of Adverse Events After Stopping Anticoagulation Post-Afib Ablation: JAMA
After IPTW adjustment, OAC discontinuation was linked to a higher incidence of thromboembolism (0.86 vs. 0.37 per 100 ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
America's Silent Epidemic Worsens: Adverse Drug Events Now the Third Leading Cause of Death
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 ...
Ophthalmology Times3d
Floppy iris syndrome risk: Study finds women more susceptible, key drugs identified
Intraoperative floppy iris syndrome is associated with an increased rate of severe intraoperative complications and greater ...