The assessment identifies findings about EUA processes, review prioritization, sponsor support, stakeholder outreach and more

If your email program has trouble displaying this email, view as a webpage. Independent Assessment of the FDA's EUA Process for COVID-19 Tests Today, the U.S. Food and Drug Administration (FDA) posted information about an assessment of the Emergency Use Authorization (EUA) process that the FDA's Center for Devices and Radiological Health (CDRH) implemented to help authorize COVID-19 tests during the public health emergency. The assessment was conducted by Booz Allen Hamilton, an independent, third-party contractor. This assessment focuses on how CDRH prioritized processing of EUA requests, review times, accuracy and reliability of COVID-19 tests, a comparison to prior public health emergencies, and requestors' perspectives.    The web posting includes:   Booz Allen Hamilton's Emergency Use Authorization Assessment and recommendations  CDRH's perspectives and next steps Read More Questions? If you have questions email COVID19Dx@fda.hhs.gov.

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