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1 results

  • Chapter 10 - The RADx® Regulatory Core and Its Role in COVID-19 Emergency Use Authorizations

  • Edited by Steven C. Schachter, Harvard Medical School, Wade E. Bolton, VentureWell/Rapid Acceleration of Diagnostics (RADx)
  • Book:
    Accelerating Diagnostics in a Time of Crisis
    Published online:
    06 January 2024
    Print publication:
    07 March 2024, pp 194-210

  • Summary

    The Rapid Acceleration of Diagnostics (RADx®) Regulatory Core was established as part of the National Institutes of Health (NIH)-funded RADx US response to the COVID-19 pandemic. The RADx Regulatory Core is charged with supporting COVID-19 in vitro diagnostic manufacturers admitted into the RADx program with the goal of obtaining Emergency Use Authorization (EUA) and planning for full authorizations to increase COVID-19 testing throughput on the US market. This chapter outlines the EUA process and how it differs from full authorization and describes the inception and evolution of the RADx Regulatory Core, including collaborations made with the NIH, the US Food and Drug Administration, and industry sponsors to successfully bring new tests to the market.