CDER Reorganization Enters New Phase, Naming Three New Offices

Some INDs, NDAs and BLAs may be affected during the implementation process. 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

Genedrive Gets FDA Clearance for Baby Deafness Diagnostic

The diagnostic test can screen infants for the deafness-causing genetic mutation in under 30 minutes. 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
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