FDA Prioritizes Emergency-Use Reviews For Coronavirus At-Home Tests, Doubles Review Staff
Executive Summary
A top FDA official said the agency has more than doubled its virology review staff to handle the cascade of EUA applications. He said the agency is prioritizing certain COVID-19 diagnostics during a recent webinar.
You may also be interested in...
Premarket Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic
FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.
Premarket Review Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic
FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.
Available Online And Flying: Quest Teams With Walmart To Deliver COVID-19 Tests By Drone
Look! Up in the sky! It’s a bird! It’s a plane! It’s … a COVID-19 test from Quest Diagnostics. Goal of pilot program is to determine roles drones can have not only in response to pandemics, but in health care delivery and retail.