FDA Issues Guidance To Protect Children Enrolled in Clinical Trials
Executive Summary
The US FDA has published a draft guidance outlining its current thinking on ethical considerations for clinical trials of medical products, including devices, that enroll children.
You may also be interested in...
More Nightmares For Philips DreamStation Machines
The US FDA has received a significant increase in medical device reports associated with Philips DreamStation 2 machines, including fire, smoke, and burns.
Founder Of AI Tool For Predicting Progression Of Chronic Kidney Disease Discusses Technology
The Klinrisk model, a new AI-driven tool developed to predict the progression of chronic kidney disease, proved highly effective in a recent study. The model’s scientific founder told Medtech Insight the novel technology has the potential to help healthcare professionals better identify patients most at risk.
FDA Leaves Global Harmonization Working Party, Will Focus International Harmonization Efforts
Three years after joining, the US FDA announced its withdrawal from the Global Harmonization Working Party and intention to focus its work on medical device harmonization through its collaboration with the International Medical Device Regulators Forum.