FDA Gives Priority Review to Keytruda

The agency committed to completing the priority review no later than June 10. Read More

International Devices and Diagnostics Monitor

Stay ahead of the competition with this resource that brings you a global picture of the medical device regulations that affect your business. Read More

Bioness Receives CE Mark for Neuromodulation System

The wearable patch lets patients control their symptoms through gentle stimulating pulses. Read More

483sOnline.com Your Personal Pre-inspection Toolkit

Rest easy knowing you can identify exactly what FDA investigators are focusing on – before they show up! Read More
The Solutions Center