5 Key Facts to Know About FDA’s Emergency Use Authorization Process

The current COVID-19 global pandemic continues to remain out of control. As we write this blog, over 60,000 new infections are being reported on a daily basis in the United States, with a cumulative total of over 4 million cases and over 150,000 deaths reported since the pandemic first began here.

Regulatory NewsNaveen AgarwalJuly 31, 2020COVID-19, FDA, FDA Emergency Use Authorization, medtechComment

How MedTech is Rising to Help Combat the Coronavirus Pandemic

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA.

A Risk Management Tool for MedTech

Objective classification of adverse events has been a challenge for the industry. An outcome-based, medically-focused classification framework offers a more robust approach.