Sanofi and Regeneron’s Dupixent Gains Priority Review From FDA

Dupixent was previously shot down in April by the UK’s National Institute for Health Care and Excellence over concerns about the drug’s cost-effectiveness. 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

BioFire Diagnostics’ Pneumonia Panels Cleared by FDA

The panels give test results in approximately one hour. 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
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