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Coronavirus (COVID-19) Update: Daily Roundup for 7/10/2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The FDA issued a statement in conjunction with preparations to resume domestic inspections, guided by a new a risk-assessment system. The White House Guidelines for Opening Up America Again are providing FDA a roadmap for optimizing operations and new work arrangements, and the Centers for Disease Control and Prevention's (CDC) guidance is informing efforts related to workplace exposures to COVID-19 in non-healthcare settings. To arm FDA investigators with the most reliable and accurate information, the FDA developed a rating system to assist in determining when and where it is safest to conduct prioritized domestic inspections. The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data. The Advisory Level data will be made available to state partners who, under contract, conduct inspections of FDA-regulated entities on the agency's behalf.

    At this time, the agency is working toward restarting on-site inspections during the week of July 20. However, resuming these inspections will depend on the data about the virus' trajectory in a given state and locality and the rules and guidelines established by those state and local governments.

  • The agency issued new Emergency Use Authorizations for diagnostic tests developed by:
  • Testing updates:
    • To date, the FDA has currently authorized 173 tests under EUAs; these include 144 molecular tests, 27 antibody tests, and 2 antigen tests.

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